Atlas FDA

1992

3,665 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MODEL #340 STEALTH-TRODE+LS (K923297)Cardiotronics, Inc.1992-09-18
NU-BREDE PACKING AND DEBRIDEMENT SPONGE (K921983)Johnson & Johnson Medical, Inc.1992-09-18
CONDUCER HEAT EXCHANGER (K923311)3M Health Care, Sarns1992-09-18
BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA (K922584)Baxter Diagnostics, Inc.1992-09-18
GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) (K921929)General Devices1992-09-18
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION (K922433)Syva Co.1992-09-18
ENOXACIN 10 MCG. SENSI SISC (K923952)Becton Dickinson Microbiology Systems1992-09-18
ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT (K922557)Acufex Microsurgical, Inc.1992-09-17
SEAL RING FOR NASAL CPAP (K921499)Devilbiss Health Care, Inc.1992-09-17
IL TEST ALT, PN 35311 (K923623)Instrumentation Laboratory CO1992-09-17
STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY (K923286)Baxter Diagnostics, Inc.1992-09-17
AMBU OXYGEN REGULATOR (K921125)Amg, LLC1992-09-17
ENDOTEK ULTRA SYSTEM (K920451)Surgitek1992-09-17
MINIDAM II (K921771)Delsan Dental Systems1992-09-17
OPTICAL FRAMES (K922930)St. Germain Eyewear Intl.1992-09-17
BARTELS RUBELLA IGG EIA (K922586)Baxter Diagnostics, Inc.1992-09-17
AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR (K920068)United States Surgical, A Division of Tyco Healthc1992-09-17
KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM (K922824)Joint Medical Products Corp.1992-09-17
BARTELS RUBELLA IGM EIA (K922581)Baxter Diagnostics, Inc.1992-09-17
CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER (K921310)Cordis Corp.1992-09-17
LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED (K924217)Life Support Products, Inc.1992-09-17
AUTOVAC (K921107)Life Support Products, Inc.1992-09-17
FIRST TOUCH/VILEDON NON-WOVEN FILTER (K915752)First Touch Disposables, Inc.1992-09-17
AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR (K924215)Ambu, Inc.1992-09-16
NEOLINE(TM) (K914778)Martech Medical Products, Inc.1992-09-16
AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO (K924216)Ambu, Inc.1992-09-16
ORIGIN SECONDARY CANNULA AND TROCAR (K922460)Origin Medsystems, Inc.1992-09-16
CLEARTRAC CANNULA (K920454)Acufex Microsurgical, Inc.1992-09-16
EDM(R) INFUSION CATHETER (K914979)Peripheral Systems Group1992-09-16
PALADUR (K915898)Heraeus Kulzer, Inc.1992-09-16
ONE TOUCH IIB BLOOD GLUCOSE METER (K922888)Lifescan, Inc.1992-09-15
CN ENDOTRACHEAL TUBE HOLDER (K921698)N-C-N Products Co.1992-09-15
CENTRI-SAFE(TM) VALVE (K921500)Cardio Systems, Inc.1992-09-15
STRAPPAL (K922897)Smith & Nephew United, Inc.1992-09-15
ANI BIOCARD HCG TEST (K923030)Ani OY1992-09-15
MICRO EIA FOR OPIATE METABOLITES (K923468)Microdiagnostics, Inc.1992-09-15
SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT (K922262)Sporicidin Intl.1992-09-15
MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS (K920889)Medtronic Vascular1992-09-15
MILES URINE GLUCOSE METHOD (K923040)Heraeus Kulzer, Inc.1992-09-15
MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS (K914488)Invacare Corp.1992-09-15
NE-U04/NE U04F (K923024)Omron Healthcare, Inc.1992-09-15
ULTRACELL INSTRUMENT WIPE (K920353)Ultracell Medical Technologies, Inc.1992-09-15
YASARGIL ANEURYSM CLIPS (K922272)Aesculap, Inc.1992-09-15
PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE (K923285)Smith & Nephew, Inc.1992-09-15
MILES URINE CALCIUM METHOD (K923034)Heraeus Kulzer, Inc.1992-09-15
IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY (K923060)Becton Dickinson Advanced Diagnostics1992-09-15
UROSKOP D1, UROSKOP D2, AND UROSKOP D3 (K923049)Siemens Medical Solutions USA, Inc.1992-09-15
J-VAC BULB SUCTION RESERVOIR (K922895)Johnson & Johnson Medical, Inc.1992-09-15
NE-U07 (K922923)Omron Healthcare, Inc.1992-09-15
CEDIA DIGOXIN PLUS ASSAY (K923853)Microgenics Corp.1992-09-15
URESIL NEPHROSTOMY CATHETER (K923097)Uresil Corp.1992-09-14
SINGLE DOSE GAS INJECTOR (K923397)Escalon Medical Trek1992-09-14
THC URINE CALIBRATORS (K923386)Diagnostic Reagents, Inc.1992-09-14
IGE EIA TEST KIT (K920087)The Binding Site, Ltd.1992-09-14
BENDEREV PROTECT-A-PASS NEEDLE (K921228)Eimark Labs, Inc.1992-09-14
URESIL SUMP DRAINAGE CATHETER (K920509)Uresil Corp.1992-09-14
BRINDLEY & SMITH ET-1000 (K915100)Zmi Corp.1992-09-14
KB40-KF (K922956)Jeneric/Pentron, Inc.1992-09-14
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA (K921628)Incstar Corp.1992-09-14
URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER (K920510)Uresil Corp.1992-09-14
QD WHOLE BODY COIL, MRT-150A (K922798)Toshiba America Mri, Inc.1992-09-14
PARAGON (K922957)Jeneric/Pentron, Inc.1992-09-14
OPUS(R) TOXO-G TEST SYSTEM (K921523)Pb Diagnostics, Inc.1992-09-14
FLEXIBLE FIBER OPTIC ENDOSCOPE (K922937)Optimed Technologies, Inc.1992-09-14
SKIN SUPPORT PREP PAD (K923351)Coloplast Corp.1992-09-14
866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS (K914685)In Vitro Technologies, Inc.1992-09-14
DISPOSABLE FORCEPS (K920296)Falcon Instruments, Inc.1992-09-11
ASTECH HOME PEAK FLOW METER (K915060)Biotrine Corp.1992-09-11
BURN DRESSING (K923846)Medical Action Industries, Inc.1992-09-11
MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD (K915188)Cook Pacemaker Corp.1992-09-11
MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE (K920469)Respiratory Support Products, Inc.1992-09-11
ISOPORE TAPE (K922959)Lectec Corp.1992-09-11
SCAN BAND (K923106)Cook, Inc.1992-09-11
PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED (K923445)Hycor Biomedical, Inc.1992-09-11
TRIAD INLAY COMPOSITE (K923236)Dentsply Intl.1992-09-11
O.R. CONCEPTS CABLE HARNESS (K924264)O.R. Concepts, Inc.1992-09-11
THE PEAK (K920390)Multispiro, Inc.1992-09-11
SCANMATE III (K921878)Circadian, Inc.1992-09-11
DU PONT COMPACT DAYLIGHT SYSTEM 2000 (K922483)E.I. Dupont DE Nemours & Co., Inc.1992-09-11
DISPOSABLE SCISSORS (K920297)Falcon Instruments, Inc.1992-09-11
ROCHE ENTEROTUBE II (K922588)Roche Diagnostic Systems, Inc.1992-09-11
MOBILE ATHENA HF (K922454)Fischer Imaging Corp.1992-09-11
DISPSABLE FORCEPS, HEMOSTATS, PROBES, NEEDLE GUIDE (K922874)Supra Instruments, Inc.1992-09-11
PROSPECT GIARDIA CONTROLS (K922675)Alexon, Inc.1992-09-11
AEROSTAR (K921313)Biosafety Systems, Inc.1992-09-11
TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT (K922814)Bay Shore Medical Equipment Corp.1992-09-11
MED-TENS (K921813)Ems Dist.1992-09-11
PNEUMO-WEDGE (K921143)Kansas Creative Devices, Inc.1992-09-11
TRACE ALBUMIN-MR REAGENT (K923322)Trace Scientific , Ltd.1992-09-11
DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 (K921963)Sun Medical, Inc.1992-09-11
WATERS(TM) LC MODULE I FOR CLINICAL USE (K922388)Millipore Corp.1992-09-11
CPA/3.5 MHZ PROBE (K911435)Diasonics, Inc.1992-09-11
SPLATTER SHIELD (K915676)Chathamborough Research Group, Inc.1992-09-11
REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS (K921504)Chalgren Enterprises, Inc.1992-09-11
TECHNICON H*2 (K923237)Heraeus Kulzer, Inc.1992-09-11
KODAK EKTASCAN IMAGELINK QUALITY CONTROL WORKSTATI (K923270)Eastman Kodak Company1992-09-11
CONSENSUS(TM) BIPOLAR SYSTEM (K922560)U.S. Medical Products, Inc.1992-09-11
ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. (K914364)North American Technical Services Corp.1992-09-10
BIAD NEW DETECTOR OPTION (K923345)Trionix Research Laboratory, Inc.1992-09-10
FIRST AID KIT (K921976)The Home Emergency Room1992-09-10
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Every clearance here is in the API, with alerts when new ones post.