Atlas FDA

2012

3,135 FDA 510(k) clearances · Clearance year

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RecordFirmDate
RESPIRONICS SIMPLYCLEAR DEVICE (K122111)Respironics, Inc.2012-12-31
LIPIVIEW OCULAR SURFACE INTERFEROMETER (K122481)Tearscience, Inc.2012-12-31
LANSINOH POWERED ELECTRIC BREAST PUMP (K122474)Lansinoh Laboratories Saglik Gerecleri Tasarim San2012-12-28
OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT (K121397)SEKISUI Diagnostics, LLC2012-12-28
DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM (K123167)Medos International SARL2012-12-28
ONQ RTS (K123357)Oncology Systems, Inc.2012-12-28
NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 (K121007)Delta Med Srl2012-12-28
RAPID STRAND RX (K122764)Medi-Physics, Inc.2012-12-28
ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR (K121297)Signature Orthopaedics Pty, Ltd.2012-12-28
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE (K121549)Siam Sempermed Corp., Ltd.2012-12-27
EZ-ASSIST-FILL (K121661)Assist Fill, LLC2012-12-27
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) (K121693)Sapphire Medical Group, Inc.2012-12-27
SYNGO SINGLE SOURCE DUAL ENGERY (K122909)Siemens Medical Systems, Inc.2012-12-27
QUICK SAMPLER HOLDER (K120490)Nipro Medical Corporation2012-12-27
NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR (K123683)Aerocrine AB2012-12-27
CLEARREAD +CONFIRM (K123526)Riverain Technologies2012-12-27
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B (K122039)Kettenbach GmbH & Co. KG2012-12-27
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK (K123663)Bio-Rad Laboratories2012-12-27
PRESTIGE-MOBIE (K122749)Prestige Sporting Goods Co. , Ltd.2012-12-27
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT (K122784)Bioness, Inc.2012-12-27
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T (K123091)Imris, Inc.2012-12-27
INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS (K121653)Carl Zeiss Meditec, Inc.2012-12-27
EVA SELECT DIGITAL DENTAL IMAGING SYSTEM (K123419)Afp Imaging Corp.2012-12-27
FLEXLITE CAMERA (K122134)Spine View, Inc.2012-12-27
XPERT CT/NG (K121710)Cepheid2012-12-27
FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) (K123591)Medtronic Cryocath, LP2012-12-27
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 (K123017)Advanced Sterilization Products2012-12-26
HAMILTON-C3 (K123637)Hamilton Medical AG2012-12-21
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE (K122690)Arrow International, Inc.2012-12-21
GLOOKO LOGBOOK CHARTS (K122142)Glooko, Inc.2012-12-21
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN (K123836)Surgical Specialties Corp. Dba Angiotech2012-12-21
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR (K122944)Gemore Technology Co, Ltd.2012-12-21
STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST (K120822)Institut Straumann AG2012-12-21
DETACHATIP III (K123260)Conmed Corporation2012-12-21
VERSARATE FLOW RATE CONTROLER (K123729)Emed Technologies Corporation2012-12-21
ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON (K123341)Arthrex, Inc.2012-12-21
FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR (K113010)Famidoc Technology Co., Ltd.2012-12-21
TRANSTEK WRIST BLOOD PRESSURE MONITOR (K123669)Zhongshan Transtek Electronics Co., Ltd.2012-12-21
CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM (K123754)Philips Ultrasound, Inc.2012-12-21
PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM (K123616)Sonoscape Company Limited2012-12-21
NHANCER (K121077)Imds Operations B.V.2012-12-21
KOGENT BIPOLAR FORCEPS (K123172)Katalyst Surgical, LLC2012-12-21
PREXION 3D (K120948)The Yoshida Dental Mfg. Co., Ltd.2012-12-21
E-CUBE 7 (K123611)Alpinion Medical Systems Co., Ltd.2012-12-21
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER (K113023)Nxstage Medical, Inc.2012-12-21
X-TRA BASE (K123773)Voco GmbH2012-12-21
CENTURION VISION SYSTEM (K121555)Alcon Laboratories, Inc.2012-12-21
SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE (K122106)Veran Medical Technologies, Inc.2012-12-21
XPERT FLU (K123191)Cepheid2012-12-21
PANTHER OIS/R & V MODEL VERSION 2.0 (K122616)Prowess, Inc.2012-12-21
FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK (K122717)Tiger Medical Products, Ltd.2012-12-21
ANESTHESIA CONDUCTION NEEDLES (K120475)Shanghai Samedical & Plastic Instruments Co., Ltd.2012-12-21
KYPHON EXPRESS II INFLATABLE BONE TAMPS (K123771)Medtronic2012-12-21
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS (K112898)Lima Corporate S.P.A.2012-12-21
AB COMMAND DUAL CHANNEL FITNESS BELT (K122414)Leto Enterprises Incorporation2012-12-21
ABBOTT PLEX-ID FLU ASSAY (K121003)Abbott Laboratories2012-12-21
INTEGRA TOTAL FOOT SYSTEMS (K123000)Integra LifeSciences Corporation2012-12-21
Z-LOOK3 EVO SLM (K120793)Z-Systems AG2012-12-21
CERAMIN BRACKETS Z (K123092)Tomy, Inc.2012-12-21
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 (K122897)Invivo Corporation2012-12-21
VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F (K122609)Venous Health Systems, Inc.2012-12-21
MR4500 WHEELCHAIR (K120391)Wardray Premise, Ltd.2012-12-21
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) (K122961)Guangzhou Wondfo Biotech Co., Ltd.2012-12-21
GEM-STIM COMBO STIMULATOR (K122948)Gemore Technology Co, Ltd.2012-12-21
STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT (K121046)Kronus Market Development Associates, Inc.2012-12-20
REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER (K121913)Stryker Sustainability Solutions, Inc.2012-12-20
FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE (K123085)3M Company2012-12-20
SYNTEC DENTAL IMPLANT (K111189)Syntec Scientific Corp.2012-12-20
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI (K122575)Bausch & Lomb, Inc.2012-12-20
HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED (K121998)Changzhou Holymed Products Co., Ltd.2012-12-20
EXTERNAL FIXATOR SYSTEM (K122208)Christopher D. Endara2012-12-20
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH (K121027)Diamond Diagnostics, Inc.2012-12-20
OXICARE FINGERTIP PULSE OXIMETER (K122927)Delbio Incorporated2012-12-20
Q-PLUS T+ IPL LASER SYSTEM (K123168)Quanta System Spa2012-12-20
STABILINK MIS SPINAL FIXATION SYSTEM (K123093)Southern Spine, LLC2012-12-20
NOVA ONE BLOOD GLUCOSE MONITOR (K122435)Nova Biomedical Corporation2012-12-20
GKS PRIME FLEX CR TOTAL KNEE SYSTEM (K122975)Permedica2012-12-20
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K122991)Conformis, Inc.2012-12-20
DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER (K122075)Intersurgical, Inc.2012-12-20
INVENDO C25 COLONOSCOPY SYSTEM (K121582)Invendo Medical Gbmh2012-12-20
TRUEBEAM (K123291)Varian Medical Systems, Inc.2012-12-20
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR (K123046)Siemens Healthcare Diagnostics, Inc.2012-12-20
HEALTHVIEW ECG MANAGER (K123466)Lumedx2012-12-20
PANOPTIC (K121405)Welch Allyn, Inc.2012-12-20
TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) (K123659)Actuated Medical, Inc.2012-12-20
AEROPILOT (K123499)Konica Minolta Medical & Graphic, Inc.2012-12-20
g.HIamp (K123255)G.Tec Medical Engineering GmbH2012-12-20
ENDOSCOPE REPROCESSOR OER-MINI (K120357)Olympus Medical Systems Corp.2012-12-20
AP 72OS SEMI-AUTOMATED INSTRUMENT (K112910)Hitachi Chemical Diagnostics, Inc.2012-12-20
WANDY DISPERSVIE ELECTRODE (K121268)Bio-Med USA, Inc.2012-12-20
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) (K123530)Hologic, Inc.2012-12-20
SCENIUM (K123528)Siemens Medical Solutions USA, Inc.2012-12-20
FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 (K122658)Femasys, Inc.2012-12-20
SYNGO, CT CARDIAC FUNCTION (K123585)Siemens Medical Solutions USA, Inc.2012-12-20
CURASAN OSSEOLIVE DENTAL (K111105)Curasan AG2012-12-20
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM (K112644)Lotus Bio, Ltd.2012-12-19
INTRAVASCULAR ADMINISTRATION SET (K121803)Acta Medical, LLC2012-12-19
FINN CHAMBERS AQUA (K123184)Smartpractice2012-12-19
ONTEX AND OTHER PROPRIETARY NAMES (K122603)Ontex Bvba2012-12-19
HELIO (K120628)Motion Composites2012-12-19
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Every clearance here is in the API, with alerts when new ones post.