FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
93625–93648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 01, 1997
SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518
K971266 · FPA
Faulding Medical Device Co.
General Hospital · 27d
Cleared Apr 30, 1997
COBE CENTRYSYSTEM 14 PES HEMODIALYZERS
K955592 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 510d
Cleared Apr 30, 1997
PERMOBIL CHAIRMAN L/CS 8
K960951 · ITI
Permobil AB
Physical Medicine · 415d
Cleared Apr 30, 1997
CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM
K962788 · IKZ
Gaymar Industries, Inc.
Physical Medicine · 287d
Cleared Apr 30, 1997
MD-1A GALVANIC UNIT
K964208 · EGJ
R. A. Fischer Co. Corp.
Physical Medicine · 208d
Cleared Apr 30, 1997
TUNA 5 CATHETER
K965199 · GEI
Vidamed, Inc.
General & Plastic Surgery · 125d
Cleared Apr 30, 1997
TEFGEN - LS
K965205 · NPK
American Custom Medical, Inc.
Dental · 125d
Cleared Apr 30, 1997
AURA TEK FDP
K970353 · MMW
Perimmune, Inc.
Immunology · 90d
Cleared Apr 30, 1997
STRYKER 2115 REPLACEMENT BATTERY (2115)
K970378 · KIJ
Implant Resource, Inc.
Orthopedic · 89d