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
93841–93864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1997
HERRICK ULTIMATE PUNCTUM PLUG
K963708 · LZU
Lacrimedics, Inc.
Ophthalmic · 210d
Cleared Apr 14, 1997
ARTHROCARE DERMATOLOGIC ELECTROSURGERY SYSTEM
K964849 · GEI
Arthrocare Corp.
General & Plastic Surgery · 132d
Cleared Apr 14, 1997
RAPID DRUG SCREEN
K964900 · DIO
American Bio Medica Corp.
Toxicology · 138d
Cleared Apr 14, 1997
NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE...
K964918 · FPA
Critical Device Corp.
General Hospital · 126d
Cleared Apr 14, 1997
AMERIGEL OINTMENT
K970133 · MGQ
Amerx Health Care Corp.
General & Plastic Surgery · 89d
Cleared Apr 14, 1997
PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT
K970194 · JDI
Stelkast Company
Orthopedic · 83d
Cleared Apr 14, 1997
EPIX VT
K970203 · GZJ
Empi
Neurology · 83d
Cleared Apr 14, 1997
3 DIMENSIONAL VIDEO ENDOSCOPE
K970214 · GCJ
Oktas
General & Plastic Surgery · 83d
Cleared Apr 14, 1997
KIPP MED I.V. MANIFOLD
K970255 · FPA
The Kipp Group
General Hospital · 82d
Cleared Apr 14, 1997
DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE
K970330 · CEM
Dade Intl., Inc.
Chemistry · 76d
Cleared Apr 14, 1997
VISTA MINI CAMERA SYSTEM
K970369 · GCJ
Oktas
General & Plastic Surgery · 73d
Cleared Apr 14, 1997
AQUALITE INTACT PTH
K970483 · CEW
Sealite Sciences, Inc.
Chemistry · 63d
Cleared Apr 14, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL...
K970894 · DHA
Johnson & Johnson Clinical...
Chemistry · 34d
Cleared Apr 14, 1997
DISPENS-O-DISC (TM) LEVOFLOXACIN
K971120 · JTN
Difco Laboratories, Inc.
Microbiology · 18d
Cleared Apr 14, 1997
URIC, UA, OR URIC ACID
K971133 · KNK
Carolina Liquid Chemistries Corp.
Chemistry · 18d
Cleared Apr 14, 1997
DISPENS-O-DISC SPARFLOXACIN
K971211 · JTN
Difco Laboratories, Inc.
Microbiology · 18d
Cleared Apr 11, 1997
VENISECT LASER LANCET
K955653 · GEX
Venisect, Inc.
General & Plastic Surgery · 486d
Cleared Apr 11, 1997
IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
K961924 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 329d
Cleared Apr 11, 1997
LEIBINGER IMF SCREW
K963030 · DZE
Howmedica Leibinger, Inc.
Dental · 249d
Cleared Apr 11, 1997
DERMA 20 LASER SYSTEM
K964253 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 169d
Cleared Apr 11, 1997
SMF STAINLESS STEEL BONE SCREWS
K964261 · DZL
Synthes (Usa)
Dental · 168d
Cleared Apr 11, 1997
HYBRID RESIN COMPOSITE
K964867 · KLE
Parkell, Inc.
Dental · 127d
Cleared Apr 11, 1997
DENTSPLY CAVITRON SPS SCALER SYSTEM
K970123 · ELC
Dentsply Intl.
Dental · 87d
Cleared Apr 11, 1997
ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)
K970128 · KPS
Park Medical Systems, Inc.
Radiology · 87d