FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
123625–123648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 1991
SNAP-PAK (TM)
K905112 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 52d
Cleared Jan 04, 1991
ECLIPSE ICA GLUCOSE
K905144 · CFR
Biotope, Inc.
Chemistry · 50d
Cleared Jan 04, 1991
OSTEONICS(R) 6011 HIP STEM SERIES
K905158 · JDI
Osteonics Corp.
Orthopedic · 49d
Cleared Jan 04, 1991
U.S. TYPE CRUCIATE SLOT BONE SCREW
K905333 · HWC
O'Tec Corp.
Orthopedic · 37d
Cleared Jan 04, 1991
HAGIE PIN
K905347 · JDW
O'Tec Corp.
Orthopedic · 37d
Cleared Jan 04, 1991
BROAD SELF-COMPRESSING PLATE
K905355 · HRS
O'Tec Corp.
Orthopedic · 37d
Cleared Jan 04, 1991
CORTICAL BONE SCREW (EUROPEAN STYLE)
K905357 · HWC
O'Tec Corp.
Orthopedic · 37d
Cleared Jan 04, 1991
CANCELLOUS SCREW
K905358 · HWC
O'Tec Corp.
Orthopedic · 37d
Cleared Jan 04, 1991
OSTEONICS HIP REVISION WEDGES
K905406 · JDI
Osteonics Corp.
Orthopedic · 32d
Cleared Jan 04, 1991
SYSTEMATE GGT (EPOS APPLICATION) #65414
K905662 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jan 03, 1991
IVT INTRODUCER SHEATH
K903463 · DYB
Intensive Technology, Inc.
Cardiovascular · 155d
Cleared Jan 03, 1991
ATHANS EKG STANDARDIZER
K903671 · DPS
Advanced Medical Concepts, Inc.
Cardiovascular · 142d
Cleared Jan 03, 1991
PANDA HELIUM GAS ANALYZER
K903939 · BSE
Medical Associated Services, Inc.
Anesthesiology · 129d
Cleared Jan 03, 1991
RUBEOLA IGM ELISA TEST
K904083 · LJB
Gull Laboratories, Inc.
Microbiology · 120d
Cleared Jan 03, 1991
ANATECH X-RAY GENERATOR
K904114 · IZO
Continental X-Ray Corp.
Radiology · 119d
Cleared Jan 03, 1991
MORSE BALLOON INFLATION DEVICE
K904275 · MAV
North American Instrument Corp.
Cardiovascular · 107d
Cleared Jan 03, 1991
MEDTRONIC MODEL 5301B TEST CABLE
K904602 · DXY
Medtronic Vascular
Cardiovascular · 85d
Cleared Jan 03, 1991
ACS URETHAN CORONARY GUIDING CATHETER
K904884 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 69d
Cleared Jan 03, 1991
MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
K904941 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 63d
Cleared Jan 03, 1991
TITAN GEL
K905149 · DAH
Helena Laboratories
Immunology · 49d
Cleared Jan 03, 1991
IMMUNOWELL TPO (MICROSOME) TEST
K905486 · JNL
General Biometrics, Inc.
Immunology · 28d
Cleared Jan 03, 1991
KODAK EKTASCAN MULTI-FORMAT IMAGER VARIOUS MODELS
K905566 · LMC
Eastman Kodak Company
Radiology · 22d
Cleared Jan 02, 1991
AIROX AXR. 1A
K901953 · CBK
Ferguson Medical
Anesthesiology · 246d
Cleared Jan 02, 1991
DOPPLER OPTION FOR PLATINUM
K902691 · IYN
Philips Medical Systems, Inc.
Radiology · 197d