Atlas FDA

1989

5,030 FDA 510(k) clearances · Clearance year

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RecordFirmDate
COULTER POSITIVE CONTROL CELLS (K894651)Coulter Corp.1989-09-13
LATEX EXAMINATION GLOVES (K893306)Acefit Intl., Inc.1989-09-13
ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54) (K894180)Abbott Laboratories1989-09-13
TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT (K894761)Hybritech, Inc.1989-09-13
PATIENT EXAM GLOVES(MFG: SHANGHAI HUA LING LAT FAC (K893695)Shanghai Industrial Investment Co. , Ltd.1989-09-13
PATIENT EXAMINATION GLOVES (K892774)Liaoning-Usa Corp.1989-09-13
PATIENT EXAMINATION GLOVES (VINYL) (K892754)Baxter Healthcare Corp1989-09-13
MODIFIED OSTEOANALYZER (# SPSHA110/220) (K891582)Osteon, Inc.1989-09-12
LATEX PATIENT EXAMINATION GLOVES (K894995)Orient Commercial Co., Ltd.1989-09-12
VISOSHIELD(TM), SURGICAL EYE PROTECTOR (K894516)Polamedco, Inc.1989-09-12
SYRINGE TIP ADAPTOR (K894217)Acacia, Inc.1989-09-12
THE SAFEGARD PERSONAL PROTECTION KIT (K884692)The Safegard Protection Corp.1989-09-12
NEEDLE*LESS DRUG VIAL ADAPTER (K894177)Baxter Healthcare Corp1989-09-12
MODIFIED URINARY CATHETER INTRODUCER (UCI) (K890400)Go Medical Industries Pty. , Ltd.1989-09-12
DISPOSABLE SHOE COVER (K894383)American Threshold Industries, Inc.1989-09-12
GUIDEWIRE (K890959)Guidewire Technologies, Inc.1989-09-12
RELIANCE(R) 6200 EXAMINATION CHAIR (K894018)Reliance Medical Products, Inc.1989-09-12
MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM (K894974)Resonex, Inc.1989-09-12
KRONNER SACRAL PIN GUIDE (K895172)Kronner Medical1989-09-12
LATEX EXAMINATION GLOVES (K893339)Kenmark Industrial Co., Ltd.1989-09-12
FACE PROTECTION PAK(TM) (K894905)Protech Products1989-09-12
5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER (K894054)Advanced Technology Laboratories, Inc.1989-09-12
PATIENT EXAMINATION GLOVE (LATEX) (K892035)Fine Spring Ent. Co., Ltd.1989-09-12
IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM (K894842)Imed Corp.1989-09-12
DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A (K892386)Toshiba America Medical Systems, In.C1989-09-12
SURGIFLEX LASER CONTACT TIPS (K894186)Cabot Medical Corp.1989-09-12
MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR (K894335)Midmark Corp.1989-09-12
DAIG VESSEL DILATOR (K894330)Daig Corp.1989-09-12
UNICARE LATEX EXAMINATION GLOVES (K894972)Pt. Indorub Nusaraya1989-09-12
LATEX PATIENT EXAMINATION GLOVES (K894979)Tower Rubber Industries Sdn. Bhd.1989-09-12
30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE (K894479)Bennett X-Ray Corp.1989-09-12
WRIGHT MEDICAL FETASAFE (K892501)Wright Medical Corp.1989-09-12
USCI UNCOATED GUIDING CATHETERS (K894682)C.R. Bard, Inc.1989-09-12
DISPOSABLE VINYL (PVC) EXAMINATION GLOVES (K893796)Anmei Plastic & Rubber Products Co. , Ltd.1989-09-12
OPTIMA MPT AND SPT PACEMAKERS (K891231)Telectronics, Inc.1989-09-12
LATEX EXAMINATION GLOVES (K893235)Quingdao Latex Factory1989-09-12
SKELETAL FIXATION PIN (K895173)Kronner Medical1989-09-12
COMPAT ENTERAL FEED PUMP 199235 & 199240 (K891575)Sandoz Nutrition1989-09-12
CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM (K895219)Orthopedic Systems, Inc.1989-09-12
CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM (K895218)Orthopedic Systems, Inc.1989-09-12
PHASE 2 TRANSCRANIAL PROBE (K894163)Biosound, Inc.1989-09-12
CORTICAL SCREW (K895217)Orthopedic Systems, Inc.1989-09-12
SURGI SQUEEZ (K894927)Ethox Corp.1989-09-11
P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT (K893872)Johnson & Johnson Professionals, Inc.1989-09-11
PATIENT EXAMINATION GLOVES (LATEX) (K891509)Delaware Industries, Inc.1989-09-11
POWDER FREE VINYL (PVC) EXAM GLOVES (K893294)King Handy Five Corp.1989-09-11
VKG 2000 VIDEO KERATOMETER (K893968)Technitex, Inc.1989-09-11
STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE (K894398)Pymah Corp.1989-09-11
ARTROMOT(TM) CPM DEVICES (K895015)Buckman Co., Inc.1989-09-11
PROFECT EXAMINATION GLOVES (K893280)Shanghai Latex Factory1989-09-11
INTERMEDICS POWER BROACH IMPACTOR (K895121)Intermedics Orthopedics1989-09-11
AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER (K893833)Acoustic Imaging1989-09-11
STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI. (K894399)Pymah Corp.1989-09-11
MODEL #510/515 GENERAL TRANSPORT STRETCHER (K895016)Midmark Corp.1989-09-11
PATIENT EXAMINATION GLOVES (LATEX) (K892620)Permark Sdn. Bhd.1989-09-11
PATIENT EXAMINATION GLOVES (LATEX) (K892684)Baldur Systems Corp.1989-09-11
ACE ORTHOPAEDIC WASHERS (K895107)Buckman Co., Inc.1989-09-11
PATIENT EXAM GLOVES (MFG. SHANGHAI - CHANGZHENG) (K892182)Grand Monde Trading Co., Inc.1989-09-11
VINYL EXAMINATION GLOVES (K893100)Tong Shiung Plastics Industry1989-09-11
OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS (K894124)Osteonics Corp.1989-09-11
VINYL EXAMINATION GLOVES (NON-STERILE) (K894025)Good Glove Corp.1989-09-11
STERILE PATIENT EXAMINATION GLOVES (LATEX) (K893095)Asia Way Trading, Inc.1989-09-11
MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE (K895010)Mentor O & O, Inc.1989-09-11
WHEELCHAIR STUMP SUPPORT (K890178)Gerber Chair Mates, Inc.1989-09-11
LATEX EXAMINATION GLOVES (K893932)Ngai Hing Latex Gloves Mfg. Co.1989-09-11
DISPOSABLE IV INDUCTION COVER (K894427)Central Plastic, Inc.1989-09-11
PERSONAL BACK WITH FIP KIT (K894770)Canadian Posture and Seating Centre, Inc.1989-09-11
LATEX EXAMINATION GLOVES (K893279)Safetytech Sdn. Bhd.1989-09-11
PATIENT EXAMINATION GLOVES (LATEX) (K892623)Globe Ent., Inc.1989-09-11
ZIGGY MEDICHAIR (K895165)Laszlo Corp.1989-09-11
GLOBE PATIENT EXAMINATION GLOVES (K893159)Lucky and Happy, Inc.1989-09-11
LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT (K893722)Lori Medical Laboratories, Inc.1989-09-08
PROLONG INTRAVASCULAR CATHETER (K893965)Baxter Healthcare Corp1989-09-08
CEFIXIME 5 MCG SENSITIVITY DISKS (K894829)Difco Laboratories, Inc.1989-09-08
(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE (K894845)Meridian Diagnostics, Inc.1989-09-08
IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT (K894049)Pantex, Div. Bio-Analysis, Inc.1989-09-08
INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM (K894612)Intertech Resources, Inc.1989-09-08
ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID (K875317)Electro Therapeutic Devices, Inc.1989-09-08
BIPOLAR ELECTROSURGICAL SNARE (K893553)Everest Medical Corp.1989-09-08
GASTRO ENTEROLOGICAL BIOPTOME (K894419)Symbiosis Corp.1989-09-08
STERILE NATURAL LATEX SURGICAL GLOVES (K892108)Ruhn Chang Industrial Co., Ltd.1989-09-08
LATEX EXAMINATION GLOVES (K893263)Regent Group Co., Ltd.1989-09-08
NOETIX, BIOPSY NEEDLE (K893992)Noetix, Inc.1989-09-08
LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT (K893721)Lori Medical Laboratories, Inc.1989-09-08
ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) (K884709)Primrose Medical, Inc.1989-09-08
CPAP MASK (K894690)Devilbiss Health Care, Inc.1989-09-08
RUBENSTEIN URETERAL STONE FRAGMENT BRUSH (K885168)Boston Scientific Corp1989-09-08
DMI SERIES 90 EXAMINATION TABLE (K894788)M.D. Intl., Inc.1989-09-08
LAMANO DIRECTORS (K894592)Marlo Surgical Technology1989-09-08
PATIENT EXAMINATION GLOVES (VINYL) (K892191)Hsing YI Plastics Processing Co, Ltd.1989-09-08
LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT (K893723)Lori Medical Laboratories, Inc.1989-09-08
EPLAB (ELECTROCARDIOGRAPHIC MONITOR) (K893836)Quinton Electrophysiology Corp.1989-09-08
ESOPHAGEAL AND PYLORIC BALLOON DIALATORS (K884712)Primrose Medical, Inc.1989-09-08
PATIENT EXAMINATION GLOVES (K893050)Paratex Product Co., Ltd.1989-09-08
TRIGLYCERIDE (GPO) TRINDER REAGENT (K894063)Sigma Diagnostics, Inc.1989-09-07
PINSET (K884970)Safety Diagnostics, Inc.1989-09-07
ELSCINT'S EXEL 2400E CT SCANNER (K894542)Elscint, Inc.1989-09-07
NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM (K894218)Nova Biomedical Corp.1989-09-07
PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP (K894783)Baxter Healthcare Corp1989-09-07
DEVON DISPOSABLE HEAD POSITIONER COVER (K894170)Devon Industries, Inc.1989-09-07
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Track 1989 automatically

Every clearance here is in the API, with alerts when new ones post.