Atlas FDA

1989

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

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RecordFirmDate
MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-20 (K894016)Summit World Trade Corp.1989-11-22
ACROMED BUTTON SPINAL WIRE (K895441)Acromed Corp.1989-11-22
THE SHUTTLE (TM) THREE WHEEL SCOOTER (K896025)Pride Health Care, Inc.1989-11-22
MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 (K896280)Micro-Aire Surgical Instruments, Inc.1989-11-22
PROXIMAL CEMENT SPACER (K895378)Osteonics Reconstructive Products Div.1989-11-22
STATSPIN STATSAMPLER (K896206)Statspin Technologies1989-11-22
RADIUS CF (K894547)General Electric Co.1989-11-22
ACROMED DOUBLE SUBLAMINAR WIRE (K895413)Acromed Corp.1989-11-22
VS22 HIP PROSTHESIS (K896266)3M Company1989-11-22
MINI-MONITOR J7000 ICP (K893395)Ladd Research Industries, Inc.1989-11-22
STERILE HYPOALLERGENIC SURGEONS' GLOVES (K896165)Isratech Marketing Corp.1989-11-22
ACROMED BEADED SUBLAMINAR WIRE (K895439)Acromed Corp.1989-11-22
M.D.I. ADAPTER (K895549)Custom Connection Corp.1989-11-21
DSL I-PTH (DSL #8000) (K896294)Diagnostic Systems Laboratories, Inc.1989-11-21
TRICON-M TOTAL KNEE SYSTEM (K884824)Richards Medical Co., Inc.1989-11-21
FREEWAY NEBULIZER COMPRESSOR (K895592)Lifecare Services, Inc.1989-11-21
VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM (K890058)Vascular Technology Incorporated1989-11-21
LATEX PATIENT EXAMINATION GLOVE (K895497)Plymouth , Ltd.1989-11-21
LATEX SURGICAL GLOVES (K892922)Millimax Corp.1989-11-21
TENS PREP (K893604)Smith & Nephew United, Inc.1989-11-21
EPO-TRAC BY RADIOIMMUNOASSAY (RIA) (K893393)Incstar Corp.1989-11-21
AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP (K894794)Vitaid, Ltd.1989-11-21
ELECTRODELCA (K892659)Oldelft Corp. of America1989-11-21
SAS LATEX EXAMINATION GLOVES (K896217)Sas Rubber Products Co., Ltd.1989-11-21
NET STRETCHER PAD (TM) (K892892)North East Technology1989-11-21
ELITE 1500 RADIOGRAPHIC TILTING TABLE (K896324)Rms Div.1989-11-21
GAMMAMED IRIDIUM-192 SOURCE (K894381)Mick Radio-Nuclear Instruments, Inc.1989-11-21
STUDIO UNO (K894061)Eurodent, Inc.1989-11-21
FIBERVISION(TM) (K895733)Fiber Imaging, Inc.1989-11-21
PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR (K895177)Puritan Bennett Corp.1989-11-21
CARIBBEAN LATEX PRODUCTS EXAMINATION GLOVES (K894751)Caribbean Latex Products, Inc.1989-11-21
LATEX EXAMINATION GLOVES (K893937)Sai Latex Private , Ltd.1989-11-21
HWA TEH EXAMINATION GLOVES (K896251)Hwa Teh Industrial Sdn. Bhd.1989-11-21
SOFT SUCTION ADAPTER (K895684)Applied Medical Technologies1989-11-20
ORTHOMET PLUS TOTAL KNEE SYST, TITANIUM TIBIAL PEG (K893040)Orthomet, Inc.1989-11-20
NOVA GEL(TM) T SM/RNP (K896459)Inova Diagnostics, Inc.1989-11-20
NOVA GEL(TM) T SS-A/SS-B (K896460)Inova Diagnostics, Inc.1989-11-20
NOVA GEL(TM) T SCL-70 (K896461)Inova Diagnostics, Inc.1989-11-20
ZIRCONIA CERAMIC HEAD ADD'L SIZES (K896204)Richards Medical Co., Inc.1989-11-20
NOVA GEL(TM) T JO-1 (K896462)Inova Diagnostics, Inc.1989-11-20
ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE (K896310)Acufex Microsurgical, Inc.1989-11-20
IDEIA HERPES SIMPLEX VIRUS TEST (K871877)Boots-Celltech Diagnostics, Inc.1989-11-17
LIFEPORT POLYURETHANE CATHETER (K895871)Strato Medical Corp.1989-11-17
GE MR MAX SYSTEM (K895794)GE Medical Systems1989-11-17
HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL (K894402)Hipgraphics, Inc.1989-11-17
BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT (K894604)Biopro, Inc.1989-11-17
POROUS-COATED TITANIUM ACETABULAR CUP (K894965)Dow Corning Wright1989-11-17
FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE (K895245)Optimed Technologies, Inc.1989-11-17
VISION PHENYTOIN (K896074)Abbott Laboratories1989-11-17
MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD (K891259)Diamond Medical Equipment, Inc.1989-11-17
ENTRAPPING FILTER (K896116)Cadema Medical Products, Inc.1989-11-17
EAGLE DS (K895164)American Sterilizer Co.1989-11-17
FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT (K896222)Nichols Institute Diagnostics1989-11-17
THE COMFORTABLE CANNULA (K896036)Comfortable Concepts Corp.1989-11-17
PAPPAS TRI-FLANGE VENTILATION TUBE (K895242)Richards Medical Co., Inc.1989-11-17
ORTHOPHOS AND ORTHOPHOS C (K895467)Siemens Medical Solutions USA, Inc.1989-11-17
LATEX PATIENT EXAMINATION GLOVES (K895716)Lizhu Sanitary Materials Factory1989-11-17
SPORVIEW CULTURE MEDIA (K890754)Spsmedical Supply Corp.1989-11-17
FEMORAL ANGIOGRAPHY DRAPE (K896088)Medical Plastics, Inc.1989-11-17
PROTOFLUOR Z (K893038)Helena Laboratories1989-11-17
POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT (K895607)Exactech, Inc.1989-11-17
URETHRAL BALLOON DILATION CATHETER SET (K892855)Cook Urological, Inc.1989-11-17
PATIENT EXAMINATION GLOVES (K895557)Moeller Chemicals, Inc.1989-11-17
OLYMPUS PK(TM) TP (K893124)Fujirebio Diagnostics,Inc.1989-11-17
TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM (K892342)Bay Shore Medical Equipment Corp.1989-11-17
LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX) (K893351)China National Medicines & Health Prod. I/E Corp.1989-11-17
TARGET OPIATES-R (K890978)V-Tech, Inc.1989-11-17
SKINTEX LATEX EXAMINATION GLOVES (K895227)Fabrica DE Plasticos Mexicanos Del Sur. S.A.1989-11-16
MODEL IR103 SURGICAL LASER SYSTEM (K895247)Niic U.S.A., Inc.1989-11-16
LATEX EXAMINATION GLOVES (POWDER-FREE/HYPO-ALLER.) (K894497)Safeskin Corp.1989-11-16
LATEX PATIENT EXAMINATION GLOVE (K895023)Beijing Latex Factory1989-11-16
MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM (K892359)Niic U.S.A., Inc.1989-11-16
LIGHT COAGULATOR LC 250 (K881334)Nk-Optik GmbH1989-11-16
LATEX PATIENT EXAMINATION GLOVES (K895194)Waterwide Sdn. Bhd.1989-11-16
RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS (K893377)Richards Medical Co., Inc.1989-11-16
POLY-FLEX LATEX EXAMINATION GLOVES (K895499)Pacific Delta Medical Supply1989-11-16
CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS (K893499)Cmsi1989-11-16
ABTEX OR JUTAMAL LATEX EXAMINATION GLOVES (K895340)Jutamal Industry1989-11-16
AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER* (K896434)United States Surgical, A Division of Tyco Healthc1989-11-16
LATEX PATIENT EXAMINATION GLOVES (K895459)The Emulision Glove Factory of the Thirteenth1989-11-16
QCR SYSTEM I AND QCR SYSTEM II (K893380)Bremer Mfg. & Tool Co., Inc.1989-11-16
MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER (K895239)Niic U.S.A., Inc.1989-11-16
BACTERIAL AND VIRAL FILTER (K895233)F.L.W. Plastics, Inc.1989-11-15
EPI-CATH(TM) EPIDURAL CATHETER (K895204)Abbott Laboratories1989-11-15
V*S*R(TM) SCOPE (K895545)Vsr Enterprises Corp.1989-11-15
STERILE LATEX SURGEON'S GLOVES (K894928)Gigantic International Corp.1989-11-15
C.P.A.P. VALVE AND C.P.P.A. KIT (K895360)Ballard Medical Products1989-11-15
POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W (K894056)Shimadzu Medical Systems1989-11-15
TECA NEUROMAPPER 1620, BRAIN MAPPER (K894088)Teca, Inc.1989-11-15
MODEL 8750 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENE. (K895841)Everest Medical Corp.1989-11-15
1989 SOFTWARE REVISION TO THE BMT-1100 (K894714)Bruker Medical Imaging, Inc.1989-11-15
LEUKOSPORT(TM) ADHESIVE TAPE (K894367)Beiersdorf, Inc.1989-11-15
DIGICAM LHP (VIDEO INTERFACE OPTION) (K895668)Siemens Gammasonics, Inc.1989-11-15
BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C (K895034)Yamato Medical Corp.1989-11-15
SONOCA ULTRASONIC SURGICAL SYSTEM (K893926)Holl Meditronics, Inc.1989-11-14
SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK) (K895454)Advance Medical Designs, Inc.1989-11-14
HEMOSTASIS VALVE (K895214)Applied Vascular Devices, Inc.1989-11-14
SMYLON (DENTAL STAIN ERASER) (K891338)The Smylon Co.1989-11-14
ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION (K894712)Gen-Probe, Inc.1989-11-14
BREVET DISPOSABLE CONNECTORS (K895753)Brevet, Inc.1989-11-14
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Track 1989 automatically

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