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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
90625–90648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 1998
REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM
K972242 · MXC
Medtronic Vascular
Cardiovascular · 214d
Cleared Jan 16, 1998
AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
K972332 · GXN
Aesculap, Inc.
Neurology · 207d
Cleared Jan 16, 1998
BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED
K972562 · GEI
Electroscope, Inc.
General & Plastic Surgery · 191d
Cleared Jan 16, 1998
SERVOTRONIC EC100 SYSTEM
K972857 · HBC
Medicon EG
Neurology · 168d
Cleared Jan 16, 1998
OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT
K972967 · JWH
Osteonics Corp.
Orthopedic · 158d
Cleared Jan 16, 1998
SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON...
K973046 · GCJ
General Surgical Innovations
General & Plastic Surgery · 154d
Cleared Jan 16, 1998
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW
K973309 · HWC
Vilex, Inc.
Orthopedic · 135d
Cleared Jan 16, 1998
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET
K973633 · OKS
Atrion Medical Products, Inc.
Ophthalmic · 183d
Cleared Jan 16, 1998
POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE
K973830 · LYY
Safe Glove , Ltd.
General Hospital · 101d
Cleared Jan 16, 1998
RAC 2A MODULE HOUSING
K973984 · CCK
Marquette Medical Systems, Inc.
Anesthesiology · 88d
Cleared Jan 16, 1998
METRON QA-510 SPO2 ANALYZER
K973991 · DQA
Metron U.S., Inc.
Anesthesiology · 87d
Cleared Jan 16, 1998
ADVANTAGE EMG SYSTEM, MODEL #A100
K974010 · IKN
Advantage Medical Division of Cme...
Neurology · 87d
Cleared Jan 16, 1998
TIMESH SYSTEM
K974017 · HRS
Sofamor Danek USA,Inc.
Orthopedic · 86d
Cleared Jan 16, 1998
RECHARGEABLE BATTERY PART NUMBER GL825-200
K974061 · DXN
Alexander Mfg. Co.
Cardiovascular · 81d
Cleared Jan 16, 1998
STARLIGHT PULSED DIODE ARRAY LASER SYSTEM
K974346 · GEX
Star Medical Technologies, Inc.
General & Plastic Surgery · 58d
Cleared Jan 16, 1998
LITE TOUCH ERBIUM LASER TREATMENT SYSTEM
K974460 · GEX
Lorad Corp.
General & Plastic Surgery · 52d
Cleared Jan 16, 1998
SCANTECH LASER SCANNER
K974633 · GEX
Phantom Technologies, Inc.
General & Plastic Surgery · 35d
Cleared Jan 16, 1998
PDI STERILE LUBRICATING JELLY
K974768 · KMJ
Nice-Pak Products, Inc.
General Hospital · 25d
Cleared Jan 16, 1998
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
K974818 · MMI
Radiometer America, Inc.
Chemistry · 24d
Cleared Jan 14, 1998
AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM
K973953 · IXI
Aktina Medical Physics Corp.
Radiology · 90d
Cleared Jan 14, 1998
MODEL 37-185
K973960 · LHN
Victoreen, Inc.
Radiology · 90d
Cleared Jan 14, 1998
120 LEAF MULTILEAF COLLIMATOR
K973963 · IYE
Mitsubishi Electronics America, Inc.
Radiology · 90d
Cleared Jan 14, 1998
ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K974394 · JTN
Oxoid , Ltd.
Microbiology · 55d
Cleared Jan 13, 1998
JOBST ATHROMBIC PUMP/SLEEVE
K970922 · JOW
Jobst A Beiersdorf Co.
Cardiovascular · 307d