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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
168985–169008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 1979
ANTERIOR/POSTERIOR RESTORATIVE LIQUID
K790822 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 66d
Cleared Jul 06, 1979
SEAL & BOND DIRECT BONDING ORTHODONTIC
K790962 · DYH
Scientific Pharmaceuticals, Inc.
Dental · 45d
Cleared Jul 06, 1979
PAINT-ON RESTORATIVE, LIGHT CURED
K790963 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 45d
Cleared Jul 06, 1979
MODEL BP-2000 TIME-CYCLED VENTILATOR
K791186 · CBK
Bourns Medical Systems, Inc.
Anesthesiology · 11d
Cleared Jul 06, 1979
STETHOSCOPE WITH TEMPERATURE SENSOR
K791190 · BZT
National Catheter Co. Div. Mallinckrodt
Anesthesiology · 10d
Cleared Jul 05, 1979
MEDTRONIC MODEL 6957
K790429 · DTB
Medtronic Vascular
Cardiovascular · 125d
Cleared Jul 05, 1979
MODEL H63, BEHIND-THE-EAR
K790870 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 59d
Cleared Jul 05, 1979
CAM-10 BATTERY PACK (#7-001)
K791188 · CBK
Lifecare Services, Inc.
Anesthesiology · 9d
Cleared Jul 03, 1979
RESPIRAOTR, CAM-10 RBL
K790605 · CBK
Lifecare Services, Inc.
Anesthesiology · 96d
Cleared Jul 03, 1979
STRETCHER TRANSIT ISOLATER #122
K790657 · LGM
Vickers America Medical Corp.
General Hospital · 89d
Cleared Jul 03, 1979
AIRCRAFT TRANSIT ISOLATOR MODEL 121
K790658 · LGN
Vickers America Medical Corp.
General Hospital · 89d
Cleared Jul 03, 1979
SILASTIC INTRAVENOUS CATHETER UNIT
K790914 · FOZ
Dow Corning Corp. Healthcare...
General Hospital · 50d
Cleared Jul 03, 1979
SURGICAL FACE MASK
K790970 · KKX
Carapace, Inc.
General Hospital · 42d
Cleared Jul 03, 1979
FLOW LIMITER
K791017 · CAX
Timeter Instrument Corp.
Anesthesiology · 32d
Cleared Jul 03, 1979
CAM-10 PVV PORTABLE VOLUME VENTILATOR
K791033 · CBK
Lifecare Services, Inc.
Anesthesiology · 28d
Cleared Jul 03, 1979
STIMTECH NEUROMUSCULAR STIMULATOR, C 600
K791048 · IPF
Stimulation Technology, Inc.
Physical Medicine · 27d
Cleared Jul 03, 1979
MODEL MA3 BEHIND-THE-EAR MASKER/HEARING
K791071 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 21d
Cleared Jul 03, 1979
CENTRY 2 SYSTEM #016, 103, 016, 104
K791086 · FIP
Cobe Laboratories, Inc.
Gastroenterology & Urology · 21d
Cleared Jul 03, 1979
STIMULATOR, ELECTRICAL NERVE
K791158 · GZJ
Electreat, Inc.
Neurology · 12d
Cleared Jul 03, 1979
TEGTMEIER MAMMOMETER
K791221
Aztec Medical Products, Inc.
General & Plastic Surgery
Cleared Jun 28, 1979
ULTRA-FREE
K790445 · JRL
Millipore Corp.
Toxicology · 115d
Cleared Jun 28, 1979
DIMENSIONALL ROTATOR
K790753 · JRQ
American Hospital Supply Corp.
Immunology · 72d
Cleared Jun 28, 1979
SYRINGE TONOMETER
K790803
Medicor USA , Ltd.
Chemistry · 64d
Cleared Jun 28, 1979
COULTER ACCU-ZYME IIY-GT REAGENT KIT
K790812 · JPZ
Coulter Electronics, Inc.
Chemistry · 63d