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
103153–103176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1995
HEMOCHRON HNPT/FACTOR VI PT+
K945078 · GJS
International Technidyne Corp.
Hematology · 193d
Cleared Apr 28, 1995
BABYTHERM 8000 WB
K945467 · ILO
Drager, Inc.
Physical Medicine · 172d
Cleared Apr 28, 1995
SCIPOTEX
K945785 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 154d
Cleared Apr 28, 1995
SENSORI-MOTOR RATING SCALE
K946114 · IXY
Cmed
Radiology · 134d
Cleared Apr 28, 1995
PRECEDER GUIDEWIRE
K950352 · DQX
Boston Scientific Corp
Cardiovascular · 88d
Cleared Apr 28, 1995
SCIMED SCEPTOR PTCA GUIDE WIRE
K950534 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Apr 28, 1995
SCIMED SCEPTOR EXCHANGE GUIDE WIRE
K950535 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Apr 28, 1995
PRO-VIT
K950799 · HQE
M. Imonti and Associates Inc.,
Ophthalmic · 66d
Cleared Apr 28, 1995
SILASTIC BRAND FOLEY CATHETER
K951103 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 49d
Cleared Apr 28, 1995
COMFEEL PLUS CONTOUR DRESSING
K951327 · KMF
Richard Hamer Assoc., Inc.
General & Plastic Surgery · 36d
Cleared Apr 28, 1995
SCIPOTEX (PINK)
K951455 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 30d
Cleared Apr 28, 1995
SCIPOTEX (BLUE)
K951456 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 30d
Cleared Apr 28, 1995
ULTIMAX
K951467 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 29d
Cleared Apr 28, 1995
COMFIT
K951468 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 29d
Cleared Apr 28, 1995
SUNNEX FASHION CORP. NON-PRESCRIPTION SUNGLASSES
K951504 · HQY
Sunnex Fashion Corp.
Ophthalmic · 25d
Cleared Apr 27, 1995
FUJINON VIDEO LAPORASCOPE
K933544 · HIH
Fujinon, Inc.
Obstetrics & Gynecology · 644d
Cleared Apr 27, 1995
ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE
K942633 · JET
Oral-B Laboratories
Dental · 328d
Cleared Apr 27, 1995
RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE
K942689 · JES
Ranir/Dcp Corp.
Dental · 324d
Cleared Apr 27, 1995
RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE
K942690 · JES
Ranir/Dcp Corp.
Dental · 324d
Cleared Apr 27, 1995
ORAL-B ULTRAFLOSS WITH FLLUORIDE
K943157 · JES
Oral-B Laboratories
Dental · 300d
Cleared Apr 27, 1995
PQ5000 CT SYSTEM
K943623 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 275d
Cleared Apr 27, 1995
SERIES 400 GASTROENTEROLOGY SYSTEM
K944620 · FET
Marks & Murase
Gastroenterology & Urology · 219d
Cleared Apr 27, 1995
COLGATE PRECISION MINT WZXED DENTAL FLOSS
K944886 · JES
Colgate-Palmolive Co.
Dental · 206d
Cleared Apr 27, 1995
ELECTRODES
K944992 · JOS
Linvatec Corp.
General & Plastic Surgery · 197d