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
94105–94128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1997
DEPUY ACE AIM TITANIUM TIBIAL NAIL
K970202 · HSB
Depuy Ace Medical Co.
Orthopedic · 59d
Cleared Mar 21, 1997
FEMTEX 100% COTTON DENTLE TOUCH TAMPONS
K970232 · HEB
Regu-Tech Assoc., Inc.
Obstetrics & Gynecology · 59d
Cleared Mar 21, 1997
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
K970247 · EOB
Smith & Nephew, Inc.
Ear, Nose, Throat · 58d
Cleared Mar 21, 1997
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
K970293 · LMD
Fujifilm Medical System U.S.A., Inc.
Radiology · 56d
Cleared Mar 21, 1997
ALGOPLAQUE HYDROCOLLOID DRESSING
K970518 · MGP
Laboratoires Urgo S.A.
General & Plastic Surgery · 38d
Cleared Mar 21, 1997
TUSTEX FLAVORED CONDOMS
K970633 · HIS
Line One Laboratories
Obstetrics & Gynecology · 29d
Cleared Mar 21, 1997
PHILIPS EASY DIAGNOST
K970640 · IXR
Philips Medical Systems North...
Radiology · 29d
Cleared Mar 21, 1997
ACRYDERM GEL WOUND DRESSING
K970693 · MGQ
Acrymed, Inc.
General & Plastic Surgery · 24d
Cleared Mar 21, 1997
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
K970721 · MCY
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 22d
Cleared Mar 20, 1997
POWERED WHEELCHAIR
K962565 · ITI
Orthofab, Inc.
Physical Medicine · 262d
Cleared Mar 20, 1997
CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4
K963698 · DTY
International Biophysics Corp.
Cardiovascular · 185d
Cleared Mar 20, 1997
SURE CORE BIOPSY KIT
K963813 · KNW
Interventional Concepts, Inc.
Gastroenterology & Urology · 178d
Cleared Mar 20, 1997
CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680
K964336 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 140d
Cleared Mar 20, 1997
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
K964877 · DYF
Impra, Inc.
Cardiovascular · 105d
Cleared Mar 20, 1997
SUPERLIGHT
K964954 · INI
Wheelcare Scooters, Inc.
Physical Medicine · 99d
Cleared Mar 20, 1997
CANNULA
K965121 · HET
Origin Medsystems, Inc.
Obstetrics & Gynecology · 87d
Cleared Mar 20, 1997
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
K965132 · BTR
Mallinckrodt Medical
Anesthesiology · 87d
Cleared Mar 20, 1997
SIMAR, INC. SURGICAL DRESSING
K970020 · EFQ
Simar, Inc.
General & Plastic Surgery · 76d
Cleared Mar 19, 1997
NEUROLOGICAL OR CRANI TRAYS (PACKS)
K932221 · LRO
Associated Medical Products Co.
General & Plastic Surgery · 1412d
Cleared Mar 19, 1997
SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE
K951728 · HLI
Mira, Inc.
Ophthalmic · 706d
Cleared Mar 19, 1997
AARON VAC 2
K952558 · HKP
Aaron Medical Industries
Ophthalmic · 656d
Cleared Mar 19, 1997
THE SWIRLER NEBULIZER
K952910 · CAF
Amici, Inc.
Anesthesiology · 632d
Cleared Mar 19, 1997
GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM
K953902 · IZH
Medical Marketing Intl., Inc.
Radiology · 579d
Cleared Mar 19, 1997
NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS
K953996 · KDI
NIKKISO CO., LTD.
Gastroenterology & Urology · 573d