FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94345–94368 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 1997
COMPRESSOR/NEBULIZER #3650
K970289 · CAF
Devilbiss Health Care, Inc.
Anesthesiology · 81d
Cleared Apr 15, 1997
MODEL 1100 COLD THERAPY DEVICE
K970533 · ILO
Smith & Nephew, Inc.
Physical Medicine · 62d
Cleared Apr 15, 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
K970602 · KPI
Hollister, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 15, 1997
STEALTHSHIELD
K970755 · DRX
Vital Connections, Inc.
Cardiovascular · 43d
Cleared Apr 15, 1997
E-TYPE SPEED REDUCER CONTRA ANGLE
K970953 · KMW
Nsk Nakanishi, Inc.
Dental · 29d
Cleared Apr 15, 1997
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
K971192 · DSY
Impra, Inc.
Cardiovascular · 15d
Cleared Apr 14, 1997
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K962814 · KPM
Denver Biomaterials, Inc.
Gastroenterology & Urology · 269d
Cleared Apr 14, 1997
SNORE TEC
K963063 · LRK
Marketing Technologies, Inc.
Dental · 250d
Cleared Apr 14, 1997
HERRICK ULTIMATE PUNCTUM PLUG
K963501 · LZU
Lacrimedics, Inc.
Ophthalmic · 223d
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