Atlas FDA

2013

3,052 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL) (K130147)Small Bone Innovations, Inc.2013-05-03
QYAG LASER SYSTEM (K130250)Palomar Medical Technologies, Inc.2013-05-03
METASURG NITINOL STAPLE IMPLANT (K123926)Metasurg2013-05-03
ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER (K121243)MEDA Co., Ltd.2013-05-03
MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM (K130084)Tgm Medical, Inc.2013-05-03
NEO PS KNEE SYSTEM (K122500)Pipeline Orthopedics2013-05-03
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM) (K130334)Stryker Trauma AG2013-05-03
AG GUFFILL (K122721)Hospitech Respiration , Ltd.2013-05-03
TRIATHLON TRITANIUM TIBIAL BASEPLATE (K123486)Stryker2013-05-03
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS (K123159)Smith & Nephew, Inc.2013-05-03
STERISPINE PS PEDICLE SCREW (K130632)Safe Orthopaedics2013-05-03
SLEEK OTW PTA CATHETER (K130786)C.R. Bard, Inc.2013-05-03
DIGITAL BLOOD PRESSURE MONITOR (K123600)Little Doctor Electronic (Nantong)Co.,Ltd2013-05-03
SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM (K121404)Onset Medical Corporation2013-05-03
REVOIS PRO IMPLANT STSYEM (K113539)Riemser Arzneimittel AG2013-05-03
ARTIGLASS L. O.R. GLASS SYRINGE (K122416)Artiglass Srl2013-05-03
KNOTLESS FIBERTAK SUTURE ANCHOR (K130458)Arthrex, Inc.2013-05-03
ENSITE VELOCITY SYSTEM (K130594)St Jude Medical2013-05-03
KOMPREDA (K120597)Custom Spine, Inc.2013-05-03
AQUILION LB TRITON V4.91 (K123500)Toshibamedical Systems Corporation2013-05-02
WATERLASE IPLUS ALL TISSUE LASER (K122368)Biolase Technology, Inc.2013-05-02
SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION (K130346)Natus Neurology Incorporated2013-05-02
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT (K123953)Alfa Wassermann Diagnostic Technologies, Inc.2013-05-02
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 (K122388)Seca GmbH & Co. KG2013-05-02
INOMAX DSIR (DELIVERY SYSTEM) (K130605)Ino Therapeutics2013-05-02
GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM (K120532)Getinge Sourcing, LLC2013-05-02
CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY (K122196)Blackrock Neuromed, LLC2013-05-02
PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE (K130811)Psychemedics Corp.2013-05-02
CYNOSURE 1064NM DIODE LASER (K123971)Cynosure, Inc.2013-05-02
SUPERA VERITAS (K130591)Idev Technologies, Inc.2013-05-02
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) (K130870)Hitachi Chemical Diagnostics, Inc.2013-05-02
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER (K130039)Gambro Renal Products, Inc.2013-05-02
DVTCARE CA5 (K130174)Ossur Americas, Inc.2013-05-02
SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM (K122525)Biotest Medical Corp.2013-05-02
RANGE SPINAL SYSTEM (K130330)K2m, Inc.2013-05-02
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC (K130434)Exactech, Inc.2013-05-01
ZYGAFIX SPINAL FACET SCREW SYSTEM (K123932)X-Spine Systems, Inc.2013-05-01
FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE (K130169)Depuy Mitek, A Johnson & Johnson Company2013-05-01
ATLANTIS STRAUMANN BONE LEVEL ABUTMENT (K130216)Dentsply Implant2013-05-01
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM (K130968)C.R. Bard, Inc.2013-05-01
AGILIA INFUSION SYSTEM (K121613)Fresenius Kabi AG2013-05-01
TENDER TOUCH (K121401)Sometech Corporation2013-05-01
ELISIO-H AND ELISIO-M HEMODIALYZERS (K122347)Nipro Medical Corporation2013-05-01
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE (K123636)Bioness, Inc.2013-05-01
HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM (K122595)Dermal Life, LLC2013-05-01
BIOLOX DELTA CERAMIC FEMORAL HEADS (K130899)Zimmer GmbH2013-05-01
MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS (K130626)Ge Medical Systems Information Technologies, Inc.2013-05-01
UTF STEM, REDUCED (K123550)United Orthopedic Corporation2013-05-01
KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET (K123941)Spencer Fillmore2013-04-30
NMI PORT (K122767)Navilyst Medical, Inc.2013-04-30
NEUROSTAR TMS THERAPY SYSTEM (K130233)Neuronetics2013-04-30
STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 (K122945)Steritec Products Mfg Co, Inc.2013-04-30
DEPUY M-SPEC 36MM FEMORAL HEADS (K120599)Depuy Orthopaedics2013-04-30
ZUGA DENTAL IMPLANT SYSTEM (K122664)Zuga Medical, Inc.2013-04-30
PEREGRINE 23GA CURVED LASER PROBE (K122905)Peregrine Surgical , Ltd.2013-04-30
CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM (K122888)Cdr Systems, Inc.2013-04-30
WVSM (WIRLESS VITAL SIGNS MONITOR) (K130957)Athena Gtx2013-04-30
MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER (K130518)Luther Needlesafe Products, Inc.2013-04-30
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET (K130762)Aalto Scientific, Ltd.2013-04-29
STRAUMANN DENTAL IMPLANT SYSTEM (K130222)Straumann USA, LLC2013-04-29
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM (K123421)Olympus Medical Systems Corp.2013-04-29
SINGLE USE REPOSITIONABLE CLIP (K123601)Olympus Medical Systems Corp.2013-04-29
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE (K123470)Pas Systems International, Inc.2013-04-29
DIAGNOSTICPRO EDGE (K130406)Vidar Systems Corp.2013-04-29
COMBAT READY CLAMP (K130482)Combat Medical Systems, LLC2013-04-29
REFLOW ASPIRATION CATHETER (K123482)Volcano Corporation2013-04-29
IRIS ANTERIOR CERVICAL PLATE (K130202)Life Spine, Inc.2013-04-29
MULTI ANGLED ABUTMENT (K123755)Osstem Implant Co., Ltd.2013-04-26
PRG BARRIER COAT (K122908)Shofu Dental Corporation2013-04-26
PANTHEON SPINAL IBFD SYSTEM (K113781)Pantheon Spinal2013-04-26
AUDIT MICROCV VITAMIN D LINEARITY SET (K130764)Aalto Scientific, Ltd.2013-04-26
STERILE RADIOLUCENT SKULL PINS (K122225)Brainlab AG2013-04-26
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING (K123990)Medtronic Vascular2013-04-26
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM (K130201)Ototronix, LLC2013-04-26
BODYTRONIC 200 (K123921)Bauerfeind AG2013-04-26
CG+ ARROW PICC POWERED BY ARROW VPS STYLET (K130876)Arrow International, Inc.2013-04-26
ICRCO 3600M (K122510)Icrco, Inc.2013-04-26
MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR (K120984)Masimo Corporation2013-04-26
ABBOTT PHENOBARBITAL ASSAY (K123271)Microgenics Corp.2013-04-26
DENTO TEMP (K122549)Itena Clinical2013-04-26
PERIOTYPE X-PERT (K123386)Clinical House Europe GmbH2013-04-26
VAULT ALIF SYSTEM (K130445)Spinal USA2013-04-25
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH (K123028)Caldera Medical, Inc.2013-04-25
DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS (K123282)Ultrapure & Industrial Services, LLC2013-04-25
NVISION VLE IMAGING SYSTEM (K120800)Ninepoint Medical, Inc.2013-04-25
RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR (K122703)Biophor Diagnostics, Inc.2013-04-25
SERI SURGICAL SCAFFOLD (K123128)Allergan2013-04-25
VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE (K130860)Bio-Rad Laboratories, Inc., Clinical Systems Divis2013-04-25
AIRLIFE (K123527)Care Fusion2013-04-25
ZAVATION CERVICAL PLATE SYSTEM (K130030)Zavation, LLC2013-04-25
GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION (K130886)Glooko, Inc.2013-04-25
METANEB (K124032)Hill-Rom Services Pte, Ltd.2013-04-25
BIOMODULE 3-M1 (K123658)Zephyr Technology Corporation2013-04-24
RHYTHM VIEW (K123295)Topera, Inc.2013-04-24
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM (K120989)Nipro Diagnostics, Inc.2013-04-24
SURGISEAL TOPICAL SKIN ADHESIVE (K123936)Adhezion Biomedical, LLC2013-04-24
VASCULAR PROBE, VASCULAR PROBE ES (K130896)Synovis Life Technologies, Inc.2013-04-24
DE48-PLUS (K123915)Grass Technologies, an Astro-Med, Inc. Product Gro2013-04-24
PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM (K122826)Volcano Corporation2013-04-24
ACCELEDENT AURA (K130643)Orthoaccel Technologies, Inc.2013-04-23
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Every clearance here is in the API, with alerts when new ones post.