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
87793–87816 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 1998
ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE
K983833 · KMF
Westaim Biomedical, Inc.
General & Plastic Surgery · 41d
Cleared Dec 10, 1998
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K984099 · JPK
R&D Systems, Inc.
Hematology · 23d
Cleared Dec 10, 1998
MYOGLOBIN FLEX REAGENT CARTRIDGE
K984191 · DDR
Dade Behring, Inc.
Immunology · 17d
Cleared Dec 10, 1998
NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
K984379 · CBK
Puritan Bennett Corp.
Anesthesiology · 3d
Cleared Dec 09, 1998
MELODIE INFUSION PUMP
K980378 · FRN
Compagnie DE Developpement Aguettant
General Hospital · 313d
Cleared Dec 09, 1998
K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
K981737 · MKJ
Katecho, Inc.
Cardiovascular · 205d
Cleared Dec 09, 1998
STARTRACK INFANT GRAPHICS MONITOR
K983274 · BZK
Nellcor Puritan Bennett, Inc.
Anesthesiology · 83d
Cleared Dec 09, 1998
INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND...
K983303 · MGP
Innovative Technologies , Ltd.
General & Plastic Surgery · 79d
Cleared Dec 09, 1998
BATCH #6060 CONDUCTIVE GEL
K983964 · GYB
Skylark Device Co., Ltd.
Neurology · 33d
Cleared Dec 09, 1998
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
K984277 · JJT
Medical Analysis Systems, Inc.
Chemistry · 9d
Cleared Dec 08, 1998
CRX DIAMOND VALVE
K974096 · JXG
Phoenix Biomedical Corp.
Neurology · 404d
Cleared Dec 08, 1998
BTA STAT TEST PRESCRIPTION HOME USE
K974845 · MMW
Bard Diagnostic Sciences,Inc.
Immunology · 355d
Cleared Dec 08, 1998
CLINICAL ELECTRONIC THERMOMETER
K982140 · FLL
Valeo Corp.
General Hospital · 174d
Cleared Dec 08, 1998
PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER...
K982303 · CGA
Medisense, Inc.
Chemistry · 160d
Cleared Dec 08, 1998
PULSED OXYGEN CONSERVING DEVICE, POCD
K983459 · NFB
Medical Electronic Devices, Inc.
Anesthesiology · 69d
Cleared Dec 08, 1998
PRODIGY TOTAL BODY SOFTWARE
K983564 · KGI
Lunar Corp.
Radiology · 56d
Cleared Dec 08, 1998
ORCA-DX BONE DENSITOMETER
K983724 · KGI
Lunar Corp.
Radiology · 47d
Cleared Dec 08, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN...
K983804 · LSE
Zeus Scientific, Inc.
Microbiology · 41d
Cleared Dec 08, 1998
MAXVIEW DIAGNOSTIC WORKSTATION
K984023 · LLZ
Dynamic Healthcare Technologies, Inc.
Radiology · 26d
Cleared Dec 08, 1998
ELECSYS TROPONIN T STAT TEST
K984105 · MMI
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Dec 08, 1998
MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE
K984157 · EOQ
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 19d
Cleared Dec 07, 1998
MICRO X RESIDUAL TEST STRIPS
K974064 · MSY
Reprocessing Products Corp
Gastroenterology & Urology · 406d
Cleared Dec 07, 1998
BROWNE GA INDICATOR FOR CIDEX PRODUCTS
K981054 · JOJ
Albert Browne , Ltd.
General Hospital · 259d
Cleared Dec 07, 1998
SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE
K981665 · MMQ
Bio-Medical Sciences, Inc.
Ophthalmic · 210d