Atlas FDA

2003

3,516 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MODIFIED VERTE-STACK SPINAL SYSTEM (K030735)Medtronic Sofamor Danek2003-04-18
SYNTHES ANTERIOR CSLP SYSTEM (K030866)Synthes (Usa)2003-04-18
POLY STAT SERUM/URINE HCG TEST (K030430)Alidex, Inc.2003-04-18
PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE (K021421)Tz Medical, Inc.2003-04-18
ENDOSCOPIC PLICATION SYSTEM (K023234)Ndo Surgical, Inc.2003-04-17
ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST (K030533)Cenogenics Corp.2003-04-17
INFINTT CO., LTD. STARPACS SYSTEM (K031013)Infinitt Company2003-04-17
VELOCITY ADVANTAGE (K023939)Visioncare Devices, Inc.2003-04-17
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 (K030613)Criticare Systems, Inc.2003-04-17
GC OIA (K023947)Thermo Biostar, Inc.2003-04-17
LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT (K030176)Suretex, Ltd.2003-04-17
INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM (K030181)International Biophysics Corp.2003-04-17
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR (K030862)Blackstone Medical, Inc.2003-04-17
ANMP (ACOUSTIC NEURO MODULATION PROTOCOL) (K030791)Tinnitech, Ltd.2003-04-17
COULTER ACT 5DIFF AUTOLOADER (AL) (K030291)Beckman Coulter, Inc.2003-04-17
ARTHROSCOPY PUMP, MODEL A107 (K030402)W.O.M. World of Medicine AG2003-04-17
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT (K030855)Boston Scientific Corp2003-04-17
POWDERED VINYL EXAM GLOVES, WHITE (K030927)Copioumed Intl., Inc.2003-04-17
RIVA-SELF CURE (K030516)Southern Dental Industries, Inc.2003-04-17
OPHTEC ENCLAVATION NEEDLE (K030471)Ophtec, USA2003-04-17
GE LOGIQ 9 MODEL 2375600 (K030934)Ge Medical Systems, Inc.2003-04-17
HL888HM (K030499)Health & Life Co., Ltd.2003-04-17
2 BASIC (K030175)Capintec, Inc.2003-04-17
THERMATREK IRIS-IV INFRARED IMAGING SYSTEM (K030165)Thermatrek2003-04-16
ARTHROCARE PERCD SPINEWAND (K030954)Arthrocare Corp.2003-04-16
IMBIBE II SYRINGE (K030208)Orthovita, Inc.2003-04-16
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 (K030854)E-Z-Em, Inc.2003-04-16
PANCREATIC DRAINAGE TUBE (K021672)Aomori Olympus Co., Ltd.2003-04-16
HTS ARRAY COIL (K030540)Jockey Club Mri Engineering Center2003-04-16
A/T X-RAY 70 (K024285)Air Techniques, Inc.2003-04-16
IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR (K030385)Kawasumi Laboratories America, Inc.2003-04-15
BIOUNIVERSAL PKF (K030435)Ivoclar Vivadent, Inc.2003-04-15
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS (K030147)Lumenis, Ltd.2003-04-15
BIO UNIVERSAL (K030436)Ivoclar Vivadent, Inc.2003-04-15
GROMAN PREPMASTER (K030292)Groman, Inc.2003-04-15
DIOLASE 980 D LASER SYSTEM (K023547)American Dental Technologies, Inc.2003-04-15
LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS (K023308)Orbus Medical Technologies2003-04-14
PASCO MIC AND MIC/ID PANELS (K030620)Pasco Laboratories, Inc.2003-04-14
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES (K030362)Leonhard Lang GmbH2003-04-14
URINE MONOVETTE BORIC ACID (K024237)Sarstedt, Inc.2003-04-14
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS (K030650)Uridynamics, Inc.2003-04-14
VINCO BRAND ACUPUNCTURE NEEDLE (K024207)Helio Medical Supplies, Inc.2003-04-14
L1 SYSTEM (K024170)Pelikan Technologies, Inc.2003-04-14
LINA-BAG, MODELS LB-60, LB-100 (K030422)Lina Medical Cml Aps2003-04-14
PROANGLE DISPOSABLE PROPHY ANGLE (K030603)Pac-Dent International (Suzhou), Ltd.2003-04-14
POLRIS LV (K030186)Syneron Medical, Ltd.2003-04-14
AT HOME DRUG CUP, MODEL 9150X (K030447)Phamatech2003-04-14
PROTEC-TOP, STERIDENT, BENTO (K031022)Ronpak, Inc.2003-04-14
CERACAST-V (K030416)Mountain Medico, Inc.2003-04-14
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) (K030696)Medtronic Perfusion Systems2003-04-11
3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON (K030270)Medcomp2003-04-11
HL888HA (K030498)Health & Life Co., Ltd.2003-04-11
RDI EXTENDED RANGE CRP CALIBRATOR SET (K030772)Reference Diagnostics, Inc.2003-04-11
GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A (K030555)Biomet, Inc.2003-04-11
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET (K030320)Wako Chemicals USA, Inc.2003-04-11
GOLDWAY PATIENT MONITOR, MODEL # UT4000F (K021154)Goldway Us, Inc.2003-04-11
ONLINE DAT II CANNABINOIDS II (K030213)Roche Diagnostics Corp.2003-04-11
SK MED M201 MIXER (K022864)Sk Med2003-04-11
AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) (K030340)Cytomedix2003-04-11
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES (K031003)Medtronic Xomed, Inc.2003-04-11
DEPUY ACROMED VBR SYSTEM (K030833)Depuyacromed2003-04-10
RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM (K030437)Salton, Inc.2003-04-10
CARE STIM (K022417)Care Rehab and Orthopaedic2003-04-10
HYSTEREOSCOPY PUMP HM4 (K022449)W.O.M. World of Medicine AG2003-04-10
EVERSTICK PERIO (K030072)Stick Tech , Ltd.2003-04-10
I-125 RAPID STRAND, MODEL 7000 (K030594)Amersham Health2003-04-10
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS (K021237)CooperSurgical, Inc.2003-04-10
AAP ACROPLATE (K030909)Aap Implantate AG2003-04-10
AVANTA CARPAL FUSION PLATING SYSTEM (K030881)Avanta Orthopaedics, Inc.2003-04-10
GE 3.0T GENERAL PURPOSE FLEX COIL (K030953)Ge Medical Systems, Inc.2003-04-10
BIOFLEX PROFESSIONAL THERAPY SYSTEM (K023621)Meditech International, Inc.2003-04-10
VITALCARE URETHRAL CATHETER RED RUBBER (K023872)Vitalcare, Inc.2003-04-10
CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM (K030151)Hayes Medical, Inc.2003-04-10
CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM (K023096)Std Mfg., Inc.2003-04-10
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR (K030804)Bayer Healthcare, LLC2003-04-10
EPTFE VASCULAR PROSTHESIS; SEALPTFE (K030999)Vascutek, Ltd.2003-04-09
MIRAGE ACTIVA MASK (K030798)Resmed, Ltd.2003-04-09
NOMAD ND1000M AUGMENTED VISION SYSTEM (K030940)Microvision Incorporated2003-04-09
GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL (K030414)Sultan Chemists, Inc.2003-04-09
MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (K030905)Medamicus, Inc.2003-04-09
ALGO 3I NEWBORN HEARING SCREENER (K030823)Natus Medical, Inc.2003-04-09
WBR, MODEL HR (K030870)U.C.G. Technologies , Ltd.2003-04-09
LOOP MICROWAVE ABLATION PROBE (K023311)Vivant Medical, Inc.2003-04-09
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL (K030801)Bayer Healthcare, LLC2003-04-09
THERMO BUDDY, MODELS TB-100, TB-110, TB-120 (K023412)Hubdic Co., Ltd.2003-04-09
MID STREAM PREGNANCY TEST (K023037)Advanced Diagnostics, Inc.2003-04-09
ENVAN HEART RATE MONITOR (K030656)Envan, LLC2003-04-08
ENHANCE HUMAN SERUM ALBUMIN (K030850)Conception Technologies2003-04-08
MAS WITH OR WITHOUT SYRINGE (K021876)Marina Medical Instruments, Inc.2003-04-08
PETIT SOPHIA (K021978)Nishitomo Co., Inc.2003-04-08
TETRIS SPINAL IMPLANT (K022793)Signus Medical, LLC2003-04-08
SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM (K030069)Synthes (Usa)2003-04-08
SYNGO COLONOGRAPHY SOFTWARE PACKAGE (K030982)Siemens Medical Solutions USA, Inc.2003-04-08
BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (K030806)Bioplate, Inc.2003-04-08
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L (K023001)Home Care Technology Co., Ltd.2003-04-08
MICROS 60 (K030799)Abx Diagnostics2003-04-08
INVIGRA (K022614)Indus Medicare , Ltd.2003-04-08
REX, VERSION 3.0 (K030457)Pointdx, Inc.2003-04-08
STEREOTAXIS CATHETER ADVANCER SYSTEM (K021802)Stereotaxis, Inc.2003-04-08
EMPI ACTION PATCH IONTOPHORESIS SYSTEM (K030395)Empi2003-04-08
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Every clearance here is in the API, with alerts when new ones post.