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
162745–162768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1981
ARROW PERITONEAL LAVAGE CATHERIZATION K
K811627 · GBW
Arrow Intl., Inc.
General & Plastic Surgery · 62d
Cleared Aug 10, 1981
UROSKOP C
K811807 · KPR
Siemens Corp.
Radiology · 46d
Cleared Aug 07, 1981
TYPE FH ENDOCARDIAL LEAD
K810494 · DTB
Biotronik Sales, Inc.
Cardiovascular · 164d
Cleared Aug 07, 1981
MS-50 ULTRASONIC IMAGER
K811252 · IYO
Kontron Instruments, Inc.
Radiology · 94d
Cleared Aug 07, 1981
PLAYTEX DIGITAL TAMPON
K811385 · HEB
Playtex, Inc.
Obstetrics & Gynecology · 81d
Cleared Aug 07, 1981
PLAYTEX COMBINATION FIBER MODIFIED TAMP
K811387 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 81d
Cleared Aug 07, 1981
PLAYTEX COTTON DIGITAL TAMPON
K811388 · HEB
Playtex, Inc.
Obstetrics & Gynecology · 81d
Cleared Aug 07, 1981
PLAYTEX COTTON TAMPONS
K811389 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 81d
Cleared Aug 07, 1981
CROUCH CORNEAL PROTECTOR
K811577 · HOY
Denver Biomedicals, Inc.
Ophthalmic · 63d
Cleared Aug 07, 1981
LAPAROTOMY PADS
K811769 · GDY
South Mountain Medical
General & Plastic Surgery · 46d
Cleared Aug 07, 1981
BACTASHIELD
K811859 · FIB
Tri-Med, Inc.
Gastroenterology & Urology · 37d
Cleared Aug 07, 1981
ADAPTAID LEAD ADAPTER #365-25
K811938 · DTD
Intermedics, Inc.
Cardiovascular · 32d
Cleared Aug 07, 1981
VISITEC NEDDLE TANGE (SURGERY)
K811960
Visitec Co.
General & Plastic Surgery · 28d
Cleared Aug 07, 1981
NEUROGAR III
K812036 · GZJ
Inter Med Industries, Inc.
Neurology · 18d
Cleared Aug 07, 1981
TIDAL VOLUME MONITOR 150
K812046 · BZK
Medix Medical Electronics (U.S.A.), Inc.
Anesthesiology · 17d
Cleared Aug 07, 1981
IDS BETA-LACTAMASE DISC
K812047 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 18d
Cleared Aug 04, 1981
BOUNDARY STERILIZATION WRAP
K811819 · FRG
The Buckeye Cellulose Corp.
General Hospital · 36d
Cleared Aug 04, 1981
CALIBRATED BREATHING SYSTEM COLLECTION
K811955 · KDQ
Anchor Brush Co., Inc.
General Hospital · 34d
Cleared Aug 04, 1981
ISOLATER THP
K811981 · KOC
Tri-Med, Inc.
Gastroenterology & Urology · 22d
Cleared Aug 04, 1981
RESPIRATION RATE MONITOR 120/121
K812044 · BZQ
Medix Medical Electronics (U.S.A.), Inc.
Anesthesiology · 14d
Cleared Aug 04, 1981
DISPOSABLE PILLOW
K812079 · KME
Carpenter Co.
General Hospital · 13d
Cleared Aug 03, 1981
THREE LEVEL CONTROL SERA
K810459 · DHX
Bd Becton Dickinson Vacutainer...
Immunology · 164d
Cleared Aug 03, 1981
SUNTAN BOOTH
K810796 · FTC
Gibson'S Mfg. Corp.
General & Plastic Surgery · 133d
Cleared Aug 03, 1981
AXICARE BREAST SHELL
K811364 · HFS
Neonatal Corp.
General Hospital · 81d