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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
149833–149856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1985
SCANHEADS-ACCESS 10PV, BIOSTATIC
K843620 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 179d
Cleared Mar 12, 1985
DIGITAL ELECTRONEUROMETER S-100
K843924 · JXE
Neurotron, Inc.
Neurology · 158d
Cleared Mar 12, 1985
SCANHEADS ACCESS 10 10PV B10
K843953 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 154d
Cleared Mar 12, 1985
PENLON PPV VAPORIZER
K844007 · CAD
Penlon, Inc.
Anesthesiology · 151d
Cleared Mar 12, 1985
PENLON AM1000 ANAESTHESIA MACHINE
K844008 · BSZ
Penlon, Inc.
Anesthesiology · 151d
Cleared Mar 12, 1985
REPRO-MED SYSTEMS INFUSION DEVICE
K844401 · FRN
Repro-Med Systems, Inc.
General Hospital · 119d
Cleared Mar 12, 1985
THERMOPULS E
K844416 · IMJ
Nemectron Medical, Inc.
Physical Medicine · 118d
Cleared Mar 12, 1985
MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS
K844488 · KWL
Mecron Medical Products, Inc.
Orthopedic · 113d
Cleared Mar 12, 1985
ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
K844630 · FKX
Organon Teknika Corp.
Gastroenterology & Urology · 105d
Cleared Mar 12, 1985
MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM
K844817 · JDI
Osteonics Corp.
Orthopedic · 91d
Cleared Mar 12, 1985
PLURA-GARD CHEST DRAINAGE SYSTEM
K844942 · KDQ
Consolidated Medical Equipment, Inc.
General Hospital · 82d
Cleared Mar 12, 1985
KARECO INT'L - DOUGLE-HOOK I.V. STAND
K845031 · FOX
Kareco Intl., Inc.
General Hospital · 75d
Cleared Mar 12, 1985
PRECONNECTED URETHRAL CATHETER TRAY
K850152
Inmed Corp.
General & Plastic Surgery · 56d
Cleared Mar 12, 1985
ALBA HEALTH CARE NON-ADHERING DRESSING
K850241 · FRO
Alba Health Care
General & Plastic Surgery · 49d
Cleared Mar 12, 1985
DISPOSABLE GUEDEL AIRWAY
K850248 · CAE
Inmed Corp.
Anesthesiology · 49d
Cleared Mar 12, 1985
URETEROSCOPY CATHETER
K850335 · KOD
Inmed Corp.
Gastroenterology & Urology · 43d
Cleared Mar 12, 1985
SPECIAL PROCEDURES PACK
K850339 · FPA
Marwood Medical, Inc.
General Hospital · 43d
Cleared Mar 12, 1985
UROTRON RL9
K850348 · JJQ
Boehringer Mannheim Corp.
Chemistry · 43d
Cleared Mar 12, 1985
MENTOR PERCUTANEOUS RENAL DILATOR SET
K850355 · EZN
Mentor Corp.
Gastroenterology & Urology · 41d
Cleared Mar 12, 1985
ROTOR SYSTEMS A/S-400 & LA/S-400
K850485 · JQC
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 33d
Cleared Mar 12, 1985
SHAVE PREP TRAY
K850544 · KME
Packaging Technologies, Inc.
General Hospital · 28d
Cleared Mar 12, 1985
SECHRIST VENTILATOR/NAUTILUS CHAMBER COMBINATION
K850563 · CBF
Nautilus Environmedical Systems, Inc.
Anesthesiology · 28d
Cleared Mar 12, 1985
BSM 2000 DIALYSIS MACHINE - MODIFIED
K850569 · FKP
Organon Teknika Corp.
Gastroenterology & Urology · 28d
Cleared Mar 12, 1985
CORNING 780 FLUOROMETER/DENSITOMETER
K850617 · JQT
Corning Medical & Scientific
Chemistry · 25d