FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92809–92832 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1997
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
K972448 · JSL
Copan Italia Spa
Microbiology · 51d
Cleared Aug 20, 1997
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
K972449 · JSL
Copan Italia Spa
Microbiology · 51d
Cleared Aug 20, 1997
PASCO MIC AND MIC/ID PANELS
K972567 · JWY
Pasco Laboratories, Inc.
Microbiology · 50d
Cleared Aug 20, 1997
QUIKSTRIP ONE STEP OPIATES TEST
K972571 · DJG
Drial Consultants, Inc.
Toxicology · 41d
Cleared Aug 20, 1997
QUICK SCREEN ONE STEP AMPHETAMINE TEST
K972577 · DIT
Phamatech
Toxicology · 41d
Cleared Aug 20, 1997
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)
K972619 · DJG
Phamatech
Toxicology · 40d
Cleared Aug 20, 1997
AVL 9181 ELECTROLYTE ANALYZER
K972673 · JFP
Avl Scientific Corp.
Chemistry · 35d
Cleared Aug 19, 1997
REGULUS NAVIGATOR
K964229 · HAW
Compass Intl., Inc.
Neurology · 300d
Cleared Aug 19, 1997
NIAGARA DUAL LUMEN CATHETER
K965178 · MPB
Vas-Cath, Inc.
Gastroenterology & Urology · 238d
Cleared Aug 19, 1997
ORIGIN CARDIAC STABLIZER OCCLUDER
K970611 · DXC
Origin Medsystems, Inc.
Cardiovascular · 182d
Cleared Aug 19, 1997
CRYO CHECK APC RESISTANT PLASMA
K971222 · GGN
Precision Biologicals, Inc.
Hematology · 139d
Cleared Aug 19, 1997
ASSERACHROM TPA TEST KIT
K971519 · GGP
American Bioproducts Co.
Hematology · 116d
Cleared Aug 19, 1997
LACTOSORB TRAUMA PLATING SYSTEM
K971870 · HRS
Biomet, Inc.
Orthopedic · 90d
Cleared Aug 19, 1997
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR
K972371 · CAF
Brasamerica Medical Equipment, Inc.
Anesthesiology · 55d
Cleared Aug 19, 1997
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)
K972861 · JJS
Instrumentation Laboratory CO
Chemistry · 15d
Cleared Aug 18, 1997
ROOTFORM DENTAL IMPLANT SYSTEM
K954758 · DZE
Swiss Dental Center
Dental · 672d
Cleared Aug 18, 1997
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE...
K961942 · GYC
Radionics, Inc.
Neurology · 455d
Cleared Aug 18, 1997
TRACCELL 2000 SLIDE MAPPING SYSTEM
K964689 · JOY
Accumed Intl., Inc.
Hematology · 269d
Cleared Aug 18, 1997
CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM
K965140 · DQX
Cardio Metrics, Inc.
Cardiovascular · 238d
Cleared Aug 18, 1997
TULIP
K970129 · ELW
Richard Ting
Dental · 215d
Cleared Aug 18, 1997
DINAMAP COMPACT MONITOR
K970182 · MHX
Johnson & Johnson Medical, Inc.
Cardiovascular · 213d
Cleared Aug 18, 1997
GUIDELINE SYSTEM
K970943 · GZL
Axon Instruments, Inc.
Neurology · 157d
Cleared Aug 18, 1997
BESECURE EXTERNAL URINARY COLLECTION SYSTEM
K971271 · KNX
Urology Research Intl., Inc.
Gastroenterology & Urology · 136d
Cleared Aug 18, 1997
ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER
K971500 · FPA
Biological & Environmental Control...
General Hospital · 116d