Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO (K905801)Cemax, Inc.1991-03-22
QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM (K904019)Quantum Medical Systems, Inc.1991-03-22
DAVID SIMMONDS ANESTHESIA EXTENSION TUBES (K905384)Sparta Surgical Corp.1991-03-22
CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER (K905054)Ciba Corning Diagnostics Corp.1991-03-22
NEEDLESTICK PROTECTIVE GLOVE (K905527)Medev Corp.1991-03-22
NATURE'S CRADLE(TM) (K901763)Infant Advantage, Inc.1991-03-22
PORTA GAS COMPRESSED GAS CYLINDER CART (K910071)Sen Tech Medical Corp.1991-03-22
COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC (K900105)Cobe Laboratories, Inc.1991-03-22
LANDMARK VENOUS ACCESS DEVICE (K910799)Menlo Care, Inc.1991-03-21
BC 1213 HEALING SCREW (K904709)Minimatic Implant Technology1991-03-21
450CM GUIDE WIRE FOR G.I. USE (K910722)Terumo Corp.1991-03-21
STERILE DISPOSABLE DRAPE(S) (K910468)E.M. Adams1991-03-21
SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH (K904930)Directed Energy, Inc.1991-03-21
BC 1203 ABUTMENT TAPERED SHOULDER (K904704)Minimatic Implant Technology1991-03-21
U.S. MEDICAL PS-2000 PEDIATRIC SCALE (K910582)U.S. Medical Corp.1991-03-21
MCCONNELL SHOULDER BRACE (K910974)Mcconnell Orthopedic1991-03-21
DAHLBERG MODEL LZ BTE HEARING AID (K911096)Miracle-Ear, Inc.1991-03-21
DAHLBERG MODEL LG BTE HEARING AID (K911064)Miracle-Ear, Inc.1991-03-21
LATEX PATIENT EXAMINATION GLOVES (K911081)Medical Device Inspection Co., Inc.1991-03-21
TRICHINELLA SEROLOGY MICROTITER ELISA (K904613)Lmd Laboratories1991-03-21
STETHOSCOPE (K904547)Kimball Industries Co., Ltd.1991-03-21
BC 1207 ABUTMENT FIXED (K904706)Minimatic Implant Technology1991-03-21
FLOSCOPE MICRODOP (K910441)Advance Medical Device, Inc.1991-03-21
SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES (K904017)Siemens Ultrasound, Inc.1991-03-21
ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR (K905826)Acromed Corp.1991-03-21
RECONSTITUTION DEVICE (K910793)Baxter Healthcare Corp1991-03-21
IE MAGNETIC EXTRACTOR (K904668)Olympus Corp.1991-03-21
TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH) (K910739)V-Tech, Inc.1991-03-21
MINICLINIC OVULATION PREDICTION TEST (K910351)Vanguard Biomedical Corp.1991-03-21
EXPANDACEL NASAL TAMPONS (K904624)Ron Shippert, MD1991-03-21
BC 1211 ABUTMENT, FIXED TRANSFER PIN, INDIRECT (K904708)Minimatic Implant Technology1991-03-21
DAHLBERG MODEL LU BTE HEARING AID (K911063)Miracle-Ear, Inc.1991-03-21
P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN (K905385)Virion (U.S.), Inc.1991-03-21
U.S. MEDICAL PS-1000 PEDIATRIC SCALE (K910581)U.S. Medical Corp.1991-03-21
IMMUNOCORP COATED TUBE IRMA HCG (K910349)Immunocorp1991-03-21
ENDOTHRED ADJUSTABLE STABILITLY THEREAD (K910008)ETHICON, Inc.1991-03-21
DAHLBERG MODEL LT BTE HEARING AID (K910979)Miracle-Ear, Inc.1991-03-21
CEDIA(R) DIGOXIN SC ASSAY (K910642)Microgenics Corp.1991-03-21
AUTO SASH (TM) (K910695)Block Medical, Inc.1991-03-21
FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR (K910747)Fortress Litestyle1991-03-21
FLYNN TISSUE PROBE AND BLUNT DISSECTOR (K910713)Marlo Surgical Technology1991-03-21
U.S. MEDICAL PS-3000 NEONATAL SCALE (K910583)U.S. Medical Corp.1991-03-21
VER-MED A10017 UNIVERSAL ELECTRODE (K905489)Vermont Medical, Inc.1991-03-21
DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID (K910809)Miracle-Ear, Inc.1991-03-21
MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS (K910523)Baxter Healthcare Corp1991-03-21
OPERATIVE CHOLANGIOGRAPHIC CATHETER (K905738)Applied Vascular Devices, Inc.1991-03-21
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS (K905614)Baxter Healthcare Corp1991-03-20
KALTOSTAT WOUND DRESSING (K910059)Calgon Vestal Div.1991-03-20
KALTOSTAT WOUND PACKING (K910080)Calgon Vestal Div.1991-03-20
TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK (K910110)3M Company1991-03-20
CYTOMEGALOVIRUS ANTIBODY SCREEN (K910003)Immucor, Inc.1991-03-20
VACPAC PORTABLE ASPIRATION SYSTEM (K910271)Jedmed Instrument Co.1991-03-20
HPI SENSI-SHIELD GLOVE KIT (K910383)Hpi, Inc.1991-03-20
BCI-100 FECAL INCONTINENCE SYSTEM (K904646)Biocare Intl.1991-03-19
HOT BIOPSY FORCEPS (K905088)Esco Precision, Inc.1991-03-19
SURGICAL DRAPE (K910084)Biocor Medical, Inc.1991-03-19
MODEL 3150-64 QUADRATURE SPINE COIL IN POSITIONER (K910513)Medical Advances, Inc.1991-03-19
ELASTIC ADHESIVE BANDAGE (K910436)Byron Medical1991-03-19
TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH) (K910738)V-Tech, Inc.1991-03-19
TARGET COCAINE METABOLITE-R (K910122)V-Tech, Inc.1991-03-19
SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE (K910768)Surgitek Medical Engineering Corp.1991-03-19
RHEUMAJET CRP (K910686)Biokit USA, Inc.1991-03-19
NEURO N 50 LESION GENERATOR (K896450)Leibinger & Fischer , Ltd.1991-03-19
MODEL 3150-21 QUADRATURE SPINE COIL IN POSITIONER (K910514)Medical Advances, Inc.1991-03-19
FLEXIFLO SACKS-VINE GASTROSTOMY KITS (K910332)Abbott Laboratories1991-03-19
MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION (K904904)Graham-Field, Inc.1991-03-19
TARGET COCAINE METABOLITE-V (K910123)V-Tech, Inc.1991-03-19
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION (K910668)Ortho Diagnostic Systems, Inc.1991-03-19
REDDICK IRRIGATION/ASPIRATION SYSTEM (K910117)Ideal Medical, Inc.1991-03-19
CPI MODEL 2215/SEAMED MODEL 3400 (K910223)Seamed Corp.1991-03-19
ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE (K910875)ETHICON, Inc.1991-03-19
EEG-5400 SERIES (K902550)Nihon Kohden America, Inc.1991-03-19
IPAZYME (TM) CHLAMYDIA IGG-IGA (K910644)Savyon Diagnostics , Ltd.1991-03-19
ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE (K905282)Frantz Medical Development, Ltd.1991-03-19
CHEMTRAK ACCUMETER CHOLESTEROL TEST (K905405)Chemtrak, Inc.1991-03-19
PLATELET AGGREGATION REAGENTS (K910286)Medical Diagnostic Technologies, Inc.1991-03-19
PANTEX IRMA LH 1251 KIT (K910717)Pantex, Div. Bio-Analysis, Inc.1991-03-19
MEGA LACERATION KIT (K910368)Megadyne Medical Products, Inc.1991-03-18
ACS ANGIOSCOPIC CATHETER (K905715)Advanced Cardiovascular Systems, Inc.1991-03-18
PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT (K905067)Pioneering Technologies, Inc.1991-03-18
ELECTROSURGICAL UNIT WITH ACCESSORIES (K905654)Aspen Labs1991-03-18
ZOEX ANTISHOCK TROUSERS (K904267)Zoex Corp.1991-03-18
C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID (K910312)Ototech, Ltd.1991-03-18
PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR (K904988)Palco Laboratories, Inc.1991-03-18
CUSTOM ITE HEARING AID (K905784)Hearing Aid Co.1991-03-18
ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID (K910313)Ototech, Ltd.1991-03-18
ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID (K910311)Ototech, Ltd.1991-03-18
DEFIBRILLATOR ANALYZER MODEL QED-5 (K904159)Bio-Tek Instruments, Inc.1991-03-18
DOSE CALIBRATOR (K905796)Capintec Instruments, Inc.1991-03-18
C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID (K910314)Ototech, Ltd.1991-03-18
ACCU-MIX AMALGAMATOR (K910632)Wykle Research, Inc.1991-03-15
SENTRY SCALE (K905122)Apollo Enterprise, Ltd. Co.1991-03-15
5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU (K910669)Siemens Ultrasound, Inc.1991-03-15
SPECTRAMAT (K910068)Ivoclar North America, Inc.1991-03-15
NERVE LOCATOR/STIMULATOR (K905045)Aaron Medical Industries1991-03-15
PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS (K904937)Playtex Family Products, Inc.1991-03-15
INJECTOR, INSULIN (K905062)Sound 2000 Medical Systems, Inc.1991-03-15
DURAFILL COLOR VS (K905131)Kulzer, Inc.1991-03-15
COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST (K910260)Ge Medical Systems Information Technologies1991-03-15
MATRICS (K904756)Kerr Corporation (Danbury)1991-03-15
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Every clearance here is in the API, with alerts when new ones post.