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
75553–75576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2002
FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
K020548 · CEC
Monobind
Chemistry · 45d
Cleared Apr 05, 2002
ENVISION ANTERIOR CERVICAL PLATE SYSTEM
K020649 · KWQ
Ortho Development Corp.
Orthopedic · 36d
Cleared Apr 05, 2002
MIETHKE SHUNT SYSTEM
K020728 · HCA
Aesculap, Inc.
Neurology · 30d
Cleared Apr 05, 2002
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
K020765 · KTI
Boston Scientific Corp
Ear, Nose, Throat · 28d
Cleared Apr 05, 2002
HL168F
K020766 · DXN
Health & Life Co., Ltd.
Cardiovascular · 28d
Cleared Apr 05, 2002
KING OF HEARTS EXPRESS + AF MONITOR
K020825 · DSH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 22d
Cleared Apr 04, 2002
ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH...
K013088 · IYO
Echotech 3D Imaging Systems, Inc.
Radiology · 199d
Cleared Apr 04, 2002
BIOSUC
K013108 · KNW
Hakko Medical Co., Ltd.
Gastroenterology & Urology · 199d
Cleared Apr 04, 2002
TRUWAVE
K013210 · GZJ
Dan Med, Inc.
Neurology · 190d
Cleared Apr 04, 2002
RESECTION ABLATOR
K013369 · GEI
Linvatec Corp.
General & Plastic Surgery · 175d
Cleared Apr 04, 2002
MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM
K013428 · HAW
Ohio Medical Instrument Co., Inc.
Neurology · 170d
Cleared Apr 04, 2002
ORTHOPILOT 2
K013569 · HAW
Aesculap, Inc.
Neurology · 157d
Cleared Apr 04, 2002
MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
K013988 · BSN
Millipore Corp.
Anesthesiology · 121d
Cleared Apr 04, 2002
MEDICAL LE
K020058 · LLZ
Barco N.V.
Radiology · 86d
Cleared Apr 04, 2002
GYRUS ENT SOMNOPLASTY GENERATOR
K020067 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 85d
Cleared Apr 04, 2002
VT-1
K020154 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 77d
Cleared Apr 04, 2002
SUPPORT SLEEVE
K020258 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 69d
Cleared Apr 04, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020323 · LON
Becton, Dickinson & CO
Microbiology · 79d
Cleared Apr 04, 2002
CAL-CHEX CD PLUS
K020469 · KRX
Streck Laboratories, Inc.
Hematology · 51d
Cleared Apr 04, 2002
LONG LENGTH GAMMA NAIL
K020773 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 04, 2002
GE VIVID 3 EXPERT
K020789 · IYN
General Electric Co.
Radiology · 24d
Cleared Apr 04, 2002
GARAVENTA SUPER-TRAC TRE-52
K020933 · ING
Garaventa Accessibility
Physical Medicine · 13d
Cleared Apr 04, 2002
ADPER PROMPT
K020946 · KLE
3M Espe AG Dental Products
Dental · 10d
Cleared Apr 04, 2002
APOLLO, MODEL 1124525
K020949 · EJT
Sterngold
Dental · 10d