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
165529–165552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1981
LIQUID CRYSTAL THERM. 8 EVENT MONITOR
K802778 · KPD
Djinnii Industires, Inc.
General Hospital · 65d
Cleared Jan 09, 1981
PARAGON ELECTRO. CREATINE KINASE TEST KI
K802826 · JHX
Beckman Instruments, Inc.
Chemistry · 60d
Cleared Jan 09, 1981
RAYTHEON MEDICAL IMAGING
K802888 · IXL
Machlett Laboratories, Inc.
Radiology · 53d
Cleared Jan 09, 1981
CYTOMEGALO VIRUS & CONTROLS
K802930 · GQH
Orion Diagnostica, Inc.
Microbiology · 51d
Cleared Jan 09, 1981
CINESCOPE III RADIOGRAPHIC GENERATOR
K802941 · IZO
Controtec, Inc.
Radiology · 51d
Cleared Jan 09, 1981
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K802953 · JAA
General Electric Co.
Radiology · 50d
Cleared Jan 09, 1981
VECTOR-100 X-RAY GENERATOR
K802996 · IZO
Philips Medical Systems (Cleveland),...
Radiology · 45d
Cleared Jan 09, 1981
FLAME PHOTOMETRY REAGENTS
K803051 · JIX
Laboratory Products, Inc.
Pathology · 38d
Cleared Jan 09, 1981
TRIGLYCERIDES (UV)-2 REAGENTS
K803091 · CDT
Reagents Applications, Inc.
Chemistry · 32d
Cleared Jan 09, 1981
TRI-LEVEL RADIOASSAY CONTROL SERA
K803098 · JJY
American Diagnostic Corp.
Chemistry · 32d
Cleared Jan 09, 1981
HELENA HBA2 QUIK COLUMN METHOD
K803108 · JPD
Helena Laboratories
Hematology · 30d
Cleared Jan 09, 1981
PARALLEL CHEMICAL ANALYZER
K803135 · JJE
American Monitor Corp.
Chemistry · 28d
Cleared Jan 09, 1981
CONPHAR CAST HEELS
K803141 · LGF
Conphar, Inc.
Orthopedic · 28d
Cleared Jan 09, 1981
DOUBLE BALL JOINT
K803166 · JEC
Howmedica Corp.
Orthopedic · 25d
Cleared Jan 09, 1981
CARDIO ZYME PLUS CK-MB #65045
K803168 · JHW
Harleco
Chemistry · 25d
Cleared Jan 09, 1981
CARDIOZYME PLUS CK-TOTAL #65046
K803169 · JHS
Harleco
Chemistry · 25d
Cleared Jan 09, 1981
INTEROOM(POWERED OPHTHALMIC TABLE)
K803176 · HRS
Jocevest Interoom, Inc.
Orthopedic · 25d
Cleared Jan 09, 1981
1-125 LABELED TRIIODOTHYRONINE(T3)
K803180 · CDP
Pcl-Ria, Inc.
Chemistry · 24d
Cleared Jan 09, 1981
ARGYLE UNIVERSAL POOLE SUCTION TUBE
K803187 · JOL
Sherwood Medical Co.
General Hospital · 24d
Cleared Jan 09, 1981
ETHOX/BARRON #2000 FOOD PUMP-ENTERAL FED
K803190 · FRN
Ethox Corp.
General Hospital · 24d
Cleared Jan 09, 1981
CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT
K803216 · CIT
Union Carbide Corp.
Chemistry · 22d
Cleared Jan 09, 1981
AMES SERA-PAK ALBUMIN REAGENT KIT
K803237 · CIX
Miles Laboratories, Inc.
Toxicology · 17d
Cleared Jan 09, 1981
SOFTGOOD PRODUCTS AND SPLINTS
K803239 · IPX
Danek Medical, Inc.
Physical Medicine · 17d
Cleared Jan 09, 1981
CORNING 760 FLUOROMETER/DENSITOMETER
K803240 · JQT
Transidyne General Corp.
Chemistry · 17d