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
116377–116400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 1992
GEN-X 800-400 -- MODIFICATION
K922813 · KPR
Swiss Ray Medical Systems
Radiology · 81d
Cleared Aug 10, 1992
AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE
K910992 · JWH
Depuy, Inc.
Orthopedic · 522d
Cleared Aug 10, 1992
ANCHOR IMPLANT DENTAL ATTACHMENTS
K911575 · DZE
Anchor Implant Systems, Inc.
Dental · 490d
Cleared Aug 10, 1992
SPINE MOTION ANALYZER WITH EMG
K920256 · KQX
Orthopedic Systems, Inc.
Neurology · 202d
Cleared Aug 10, 1992
BRND SKIN PROTECTION PREP SERIES 33XX
K920794 · KMF
3M Health Care, Ltd.
General & Plastic Surgery · 171d
Cleared Aug 10, 1992
AMALGAPHASE
K921538 · EJJ
Saskan Amalgam Alloys, Inc.
Dental · 132d
Cleared Aug 10, 1992
POLYCLEAN
K921564 · EFB
Medical Polymers, Inc.
Dental · 131d
Cleared Aug 10, 1992
ACRYLASTIC
K921759 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 118d
Cleared Aug 10, 1992
TRICOPLAST
K921760 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 118d
Cleared Aug 10, 1992
STERILE GAUZE SPONGES X-RAY DETECTABLE
K922054 · GDY
Team Mfg., Inc.
General & Plastic Surgery · 98d
Cleared Aug 10, 1992
STERILE AND NON-STERILE GAUZE SPONGES
K922055 · EFQ
Team Mfg., Inc.
General & Plastic Surgery · 98d
Cleared Aug 10, 1992
AMERICAN BURN SHEET
K922143 · KME
American Silk Sutures, Inc.
General Hospital · 96d
Cleared Aug 10, 1992
MDT CASTLE BIOSIGN TEST PACK
K922212 · FRC
Mdt Corp., Inc.
General Hospital · 90d
Cleared Aug 10, 1992
DOUGLAS MEDICAL PRODUCTS, INC. IRRIGATION SET
K922318 · HRX
Douglas Medical Products Corp.
Orthopedic · 84d
Cleared Aug 10, 1992
TEMPIT-E
K922638 · EMA
Centrix, Inc.
Dental · 97d
Cleared Aug 10, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD
K922697 · JHI
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 67d
Cleared Aug 10, 1992
AQUA IONOFIL
K922853 · EMA
Voco GmbH
Dental · 56d
Cleared Aug 10, 1992
INTESTINAL SPONGES
K923041 · EFQ
Surgic Aid, Inc.
General & Plastic Surgery · 52d
Cleared Aug 10, 1992
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K923165 · JJY
Eastman Kodak Company
Chemistry · 42d
Cleared Aug 07, 1992
MODULAR FEMORAL HEAD WITH OFFSET TRUNION
K914675 · JDI
Kirschner Medical Corp.
Orthopedic · 294d
Cleared Aug 07, 1992
DISETRONIC PANOMAT PUMP
K915566 · FRN
Disetronic Medical Systems
General Hospital · 239d
Cleared Aug 07, 1992
KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM
K920396 · JWH
Kirschner Medical Corp.
Orthopedic · 190d
Cleared Aug 07, 1992
SUMMIT NUCLEAR VISION NEUROSPECT
K920958 · KPS
Summit Nuclear
Radiology · 171d
Cleared Aug 07, 1992
MEDVISION
K921484 · LLZ
Evergreen Technologies, Inc.
Radiology · 130d