FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132649–132672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 1989
BIOTROL IRON REAGENT
K890395 · JIY
Biotrol, USA, Inc.
Chemistry · 42d
Cleared Mar 08, 1989
SHAPE-ACTIO URINALYSIS CONTROLS
K890442 · JJY
Actio, Inc.
Chemistry · 40d
Cleared Mar 08, 1989
MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP
K890457 · FRN
Medtronic Minimed
General Hospital · 37d
Cleared Mar 08, 1989
MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1
K890534 · JJW
Fisher Scientific Co., LLC
Chemistry · 41d
Cleared Mar 08, 1989
ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT
K890645 · CHP
Serono-Baker Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 08, 1989
STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE
K890669 · LBR
Norfolk Scientific, Inc.
Chemistry · 27d
Cleared Mar 08, 1989
ALLEVYN TRACHEOSTOMY DRESSING
K890748 · NAD
Smith & Nephew United, Inc.
General & Plastic Surgery · 23d
Cleared Mar 06, 1989
RESPIRATORY AIRWAY TUBE MONITOR (RATM)
K883158 · BZQ
Vascucare, Inc.
Anesthesiology · 223d
Cleared Mar 06, 1989
SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
K884106 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 158d
Cleared Mar 06, 1989
EURO-MED LIGHT TOUCH BIOPSY PUNCH
K884740 · EME
Buckman Co., Inc.
Dental · 112d
Cleared Mar 06, 1989
SPINAL ANESTHESIA TRAY
K885277 · CAZ
Preferred Medical Products
Anesthesiology · 73d
Cleared Mar 06, 1989
TOTAL BILIRUBIN REAGENT, CONCENTRATED
K890070 · CIG
Trace Scientific , Ltd.
Chemistry · 56d
Cleared Mar 06, 1989
THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4
K890675 · CZW
Unipath , Ltd.
Immunology · 25d
Cleared Mar 03, 1989
STONY BROOK MODEL EECP-MC1
K882401 · DRN
Stony Brook Trading and Development...
Cardiovascular · 266d
Cleared Mar 03, 1989
AM TM SYRGICAL DRAPES
K882643 · KKX
Henley Intl.
General Hospital · 249d
Cleared Mar 03, 1989
CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200
K884025 · KNS
Circon Acmi
Gastroenterology & Urology · 162d
Cleared Mar 03, 1989
REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES
K884103 · GCX
Boehringer Laboratories
General Hospital · 155d
Cleared Mar 03, 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045 · FRO
Baxter Healthcare Corp
General & Plastic Surgery · 88d
Cleared Mar 03, 1989
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K885281 · KRA
Baxter Healthcare Corp
Cardiovascular · 66d
Cleared Mar 03, 1989
AGEN DIMERTEST EIA
K890189 · DAP
Agen Biomedical , Ltd.
Hematology · 45d
Cleared Mar 03, 1989
KOSAN ANGEL LATEX SURGICAL GLOVES (STERILE)
K890311 · KGO
Kosan Far East Ent. , Ltd.
General Hospital · 39d
Cleared Mar 03, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR TRF
K890563 · DDG
Atlantic Antibodies
Immunology · 38d
Cleared Mar 03, 1989
MALIS BIPOLAR CORD/IRRIGATION TUBING SET
K890648 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 23d
Cleared Mar 02, 1989
CAVROLAB
K882585 · IYN
Life-Tech Intl., Inc.
Radiology · 253d