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
109153–109176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1994
DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP
K921405 · HFG
Davol, Inc.
Obstetrics & Gynecology · 731d
Cleared Mar 25, 1994
E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES
K921885 · HGZ
Valleylab, Inc.
Obstetrics & Gynecology · 703d
Cleared Mar 25, 1994
4 SURE TM ENTERAL FEEDING BAG
K922402 · FPD
Boston Pacific Medical, Inc.
Gastroenterology & Urology · 673d
Cleared Mar 25, 1994
WOM HYSTEROFLATOR OP
K922632 · HIG
W.O.M. GmbH
Obstetrics & Gynecology · 751d
Cleared Mar 25, 1994
FOGLESS
K923843 · OCT
Sorex Medical
Gastroenterology & Urology · 602d
Cleared Mar 25, 1994
EXACTA-SPEZIAL
K925295 · DXN
Rudolf Riester GmbH & Co. KG
Cardiovascular · 520d
Cleared Mar 25, 1994
SEDLACEK HANDLE
K926179 · HGI
Simpson/Basye, Inc.
Obstetrics & Gynecology · 472d
Cleared Mar 25, 1994
ACTION TIGER POWERED WHEELCHAIR
K930676 · ITI
Invacare Corp.
Physical Medicine · 409d
Cleared Mar 25, 1994
WHISPER O2
K931355 · CAW
Trilogic Corp.
Anesthesiology · 373d
Cleared Mar 25, 1994
ARTHROPLANE
K932869 · HRX
Synvasive Technology, Inc.
Orthopedic · 284d
Cleared Mar 25, 1994
ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM
K933470 · HRX
Kinetix Instruments
Orthopedic · 252d
Cleared Mar 25, 1994
ESYS SYSTEM
K933492 · HET
Endolap, Inc.
Obstetrics & Gynecology · 249d
Cleared Mar 25, 1994
SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES
K934332 · HRX
Friatec Medical Inc., USA
Orthopedic · 199d
Cleared Mar 25, 1994
AUTO SUTURE DISPOSABLE ARTHROSCOPIC TROCAR AND SLEEVE
K934720 · HRX
United States Surgical, A Division of...
Orthopedic · 175d
Cleared Mar 25, 1994
PATHODX CYTOMEGALOVIRUS
K934798 · LIN
Diagnostic Products Corp.
Microbiology · 169d
Cleared Mar 25, 1994
STRYKER ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS & ACCESORIES
K935222 · GEI
Stryker Endoscopy
General & Plastic Surgery · 144d
Cleared Mar 25, 1994
PHASED ARRAY PELVIC COIL
K935450 · LNH
Medical Advances, Inc.
Radiology · 133d
Cleared Mar 25, 1994
SYNELISA ANA TOTAL
K935468 · LJM
Elias U.S.A., Inc.
Immunology · 133d
Cleared Mar 25, 1994
GRAVESPEC
K935636 · HIB
Adept-Med Intl., Inc.
Obstetrics & Gynecology · 122d
Cleared Mar 25, 1994
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
K936182 · KRB
Ohmeda Medical
Cardiovascular · 88d
Cleared Mar 25, 1994
UNSCENTED MENSTRUAL PAD TIER-1 REVIEW
K940377 · HHD
Eldari, Ltd.
Obstetrics & Gynecology · 58d
Cleared Mar 25, 1994
GRASPING FORCEPS, PUNCHES, SCISSORS
K940454 · HRX
L.A.S.E.R., Inc.
Orthopedic · 52d
Cleared Mar 25, 1994
LORI-CIC HEARING AID
K940639 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 39d
Cleared Mar 25, 1994
ELIAS ANA TOTAL
K940641 · LJM
Elias U.S.A., Inc.
Immunology · 39d