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
94129–94152 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1997
BONE SOURCE HYDROXYAPATITE
K970400 · LZK
Orthofix, Inc.
General & Plastic Surgery · 88d
Cleared May 02, 1997
PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT
K970490 · LZO
Stelkast Company
Orthopedic · 81d
Cleared May 02, 1997
RIS SCANVIEW SYSTEM (RSVS)
K970641 · LMD
Radiology Information Systems, Inc.
Radiology · 71d
Cleared May 02, 1997
MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE
K970652 · LMD
Mitra Imaging, Inc.
Radiology · 70d
Cleared May 02, 1997
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
K970665 · EPF
Williams Sound, LLC
Ear, Nose, Throat · 70d
Cleared May 02, 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K970676 · JWY
Dade Intl., Inc.
Microbiology · 67d
Cleared May 02, 1997
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
K970687 · EPF
Williams Sound, LLC
Ear, Nose, Throat · 67d
Cleared May 02, 1997
ACPII ANTERIOR CERVICAL PLATE SYSTEM
K970806 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 58d
Cleared May 02, 1997
DIGIT-GRIP WITH LCD (DGR002)
K970870 · HRW
Nk Biotechnical Corp.
Neurology · 53d
Cleared May 02, 1997
XOMED SILICONE BLOCK/STRIP
K970910 · KHJ
Xomed, Inc.
Ear, Nose, Throat · 51d
Cleared May 02, 1997
PRECISE IMPRESSION KIT
K970952 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 49d
Cleared May 02, 1997
WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER
K970974 · LZI
Williams Sound, LLC
Ear, Nose, Throat · 46d
Cleared May 02, 1997
BASIS FLEXIBLE TIP DIGITAL THERMOMETER
K971045 · FLL
Polymedica Industries, Inc.
General Hospital · 42d
Cleared May 02, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971221 · GIM
Greiner America, Inc.
Chemistry · 30d
Cleared May 02, 1997
LD-L REAGENT
K971398 · CFJ
Carolina Liquid Chemistries Corp.
Chemistry · 17d
Cleared May 02, 1997
ALB OR ALBUMIN
K971445 · CIX
Carolina Liquid Chemistries Corp.
Chemistry · 11d
Cleared May 01, 1997
INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY
K963289 · LGD
Incstar Corp.
Microbiology · 253d
Cleared May 01, 1997
FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR
K964187 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 192d
Cleared May 01, 1997
(MODIFIED) ETEST PACKAGE INSERT
K964236 · JWY
Ab Biodisk
Microbiology · 195d
Cleared May 01, 1997
FREEPIX/PIXPACS DICOM/HTTP GATEWAY
K970174 · LMD
Pixelinks, Inc.
Radiology · 111d
Cleared May 01, 1997
AMIKACIN
K970210 · JWY
Ab Biodisk
Microbiology · 100d
Cleared May 01, 1997
CHANNEL BALLOON CATHETER
K970379 · LIT
Boston Scientific Corp
Cardiovascular · 87d
Cleared May 01, 1997
ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE
K970473 · JWY
Ab Biodisk
Microbiology · 83d
Cleared May 01, 1997
SAFE-CONNECT VIAL DISPENSING SPIKE
K970789 · LHI
Faulding Medical Device Co.
General Hospital · 58d