Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
169825–169848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1979
PREGELLED DISPOSABLE EELCTRO. SERIES 600
K791140 · DRX
Hayes Products, Inc.
Cardiovascular · 22d
Cleared Jul 10, 1979
CPR CONTROL SYSTEM
K791145 · DRM
Pepin Distributing, Inc.
Cardiovascular · 22d
Cleared Jul 10, 1979
ARCOLITH 4000
K791165 · DXY
Arco Medical Products Co.
Cardiovascular · 15d
Cleared Jul 10, 1979
DEXIDE DISPOSABLE PREP SPONGE
K791166 · NAB
Dexide, Inc.
General & Plastic Surgery · 15d
Cleared Jul 06, 1979
FISSURE SEALER AND BONDING AGENT
K790788 · EBC
Scientific Pharmaceuticals, Inc.
Dental · 73d
Cleared Jul 06, 1979
COMPOSITE RESTORATIVE, PASTE/PASTE TYPE
K790789 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 73d
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