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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
143617–143640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1986
CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE
K861825 · HRH
Storz Instrument Co.
Ophthalmic · 28d
Cleared Jun 09, 1986
POLYPOLE
K861838 · FOX
Poly Medical Technologies, Inc.
General Hospital · 27d
Cleared Jun 09, 1986
PHONIC EAR
K861857 · ETW
Phonic Ear, Inc.
Ear, Nose, Throat · 26d
Cleared Jun 09, 1986
KOTEX PROFILE SHAPED MAXI PAD
K861902 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 24d
Cleared Jun 09, 1986
STERILE O. R. TOWEL
K861928 · IXX
Anago, Inc.
Radiology · 20d
Cleared Jun 09, 1986
SALIVA EJECTOR
K861934 · DYN
Carlisle Laboratories, Inc.
Dental · 20d
Cleared Jun 09, 1986
ZIMLITE LENS
K861960 · HQG
Asahi Optical Co. C/O Rosati...
Ophthalmic · 20d
Cleared Jun 09, 1986
UNITEK CERAMIC BRACKET SYSTEM
K861965 · DYW
Unitek Corp.
Dental · 21d
Cleared Jun 09, 1986
MODIFICATION OF SUNTANA SUN SYSTEM BED
K861989 · FTC
Hawaiian Tan Spa
General & Plastic Surgery · 17d
Cleared Jun 09, 1986
MODEL 43200A CARDIAC MONITOR
K861992 · DPS
Hewlett-Packard Co.
Cardiovascular · 17d
Cleared Jun 09, 1986
DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM
K861996 · KIT
Hazleton Research Products, Inc.
Pathology · 17d
Cleared Jun 09, 1986
CHICK SURGICAL LIGHT
K862010 · FTA
Professional Medical Products, Inc.
General & Plastic Surgery · 12d
Cleared Jun 09, 1986
LADD MEDICAL S-2000
K862012 · GWM
Ladd Research Industries, Inc.
Neurology · 12d
Cleared Jun 09, 1986
JEDMED CCD-02 VIDEO CAMERA SYSTEM
K862034 · FWD
Jedmed Instrument Co.
General & Plastic Surgery · 11d
Cleared Jun 06, 1986
SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN
K860584 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 108d
Cleared Jun 06, 1986
ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV
K860914 · GWK
Bio-Feedback Systems, Inc.
Neurology · 87d
Cleared Jun 06, 1986
IMMUNOMEDICS SERUM ELISA TEST SYSTEM
K861362 · CZW
Immunomedics, Inc.
Immunology · 57d
Cleared Jun 06, 1986
V. MUELLER VITAL CLIP-HEMOSTATIC CLIP
K861471 · FZP
American V. Mueller
General & Plastic Surgery · 45d
Cleared Jun 06, 1986
ENDOCARDIAL CARBON-TIP LEAD
K861481 · DTB
Pacesetter Systems
Cardiovascular · 45d
Cleared Jun 06, 1986
5 IN 1 CONNECTOR
K861757 · GAZ
Jackson Plastics, Inc.
General Hospital · 31d
Cleared Jun 06, 1986
TREACE MEDICAL FOAM INSTRUMENT PAD
K861914
Treace Medical, Inc.
General & Plastic Surgery · 18d
Cleared Jun 06, 1986
VENTREX APO B
K861919 · MSJ
Ventrex Laboratories, Inc.
Immunology · 18d
Cleared Jun 06, 1986
MICRO ANASTOMOSIS CLAMP
K861924 · DXC
Pilling Co.
Cardiovascular · 18d
Cleared Jun 06, 1986
AQUACEL SURGICAL PREP PADS
K861937
Advanced Ortho-Technology, Inc.
General & Plastic Surgery · 17d