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
92713–92736 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 1997
MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE
K972970 · MKJ
Graphic Controls Corp.
Cardiovascular · 16d
Cleared Aug 26, 1997
EVITA 2 DURA
K970165 · CBK
Drager, Inc.
Anesthesiology · 222d
Cleared Aug 26, 1997
TOTALCARE., MODULAR THERAPY SYSTEM (MTS)
K970636 · IOQ
Hill-Rom, Inc.
Physical Medicine · 187d
Cleared Aug 26, 1997
TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS
K970836 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 183d
Cleared Aug 26, 1997
BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM
K970927 · ILK
Bruno Independent Living Aids, Inc.
Physical Medicine · 166d
Cleared Aug 26, 1997
SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER
K971736 · GKZ
Sysmex Corp.
Hematology · 106d
Cleared Aug 26, 1997
BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER
K971763 · FMI
Retractable Technologies, Inc.
General Hospital · 105d
Cleared Aug 26, 1997
VALLEY FORGE BIPOLAR LOOP
K971986 · HGI
Valley Forge Scientific Corp.
Obstetrics & Gynecology · 89d
Cleared Aug 26, 1997
NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS
K972013 · KNA
National Healthcare Mfg. Corp.
Obstetrics & Gynecology · 88d
Cleared Aug 26, 1997
MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW
K972117 · LHI
Medical Specialty Innovations, Inc....
General Hospital · 82d
Cleared Aug 26, 1997
BAG DECANTER
K972134 · LHI
Remington Medical, Inc.
General Hospital · 81d
Cleared Aug 26, 1997
MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
K972135 · FPA
P/L Biomedical
General Hospital · 81d
Cleared Aug 26, 1997
DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
K972183 · HSB
Ace Medical Co.
Orthopedic · 77d
Cleared Aug 26, 1997
OSOM MONO TEST 143
K972231 · KTN
Wyntek Diagnostics, Inc.
Immunology · 71d
Cleared Aug 26, 1997
IMTEC BIOBARRIER MEMBRANE
K972240 · NPK
Imtec Corp.
Dental · 71d
Cleared Aug 26, 1997
AURECAST GF
K972319 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 67d
Cleared Aug 26, 1997
INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER
K972356 · MBI
Innovasive Devices, Inc.
Orthopedic · 62d
Cleared Aug 26, 1997
3I INNOVATIVE IMPLANTS AND COVER SCREWS
K972444 · DZE
Implant Innovations, Inc.
Dental · 57d
Cleared Aug 26, 1997
CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
K972503 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 54d
Cleared Aug 26, 1997
SURGICAL BURS AND SURGICAL DRILL BITS
K972508 · HWE
Synvasive Technology, Inc.
Orthopedic · 54d
Cleared Aug 26, 1997
METALPRIMER II
K972594 · KLE
GC America, Inc.
Dental · 46d
Cleared Aug 26, 1997
OPT80 THE TRANSPORTABLE (OPT80)
K972810 · FQO
O.P.T. USA, Inc.
General & Plastic Surgery · 29d
Cleared Aug 26, 1997
AURECAST BIO 59PF
K972939 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 67d
Cleared Aug 26, 1997
AURECAST BIO 69PF
K972940 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 67d