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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
123025–123048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 1991
HA-TI (HAND-TITANIUM SCREW) IMPLANT
K901927 · DZE
Mathys Corp. of North America
Dental · 249d
Cleared Jan 04, 1991
CONTAIN(TM) LASER PLUME FILTER
K902167 · JDY
Arbor Technologies, Inc.
Orthopedic · 234d
Cleared Jan 04, 1991
MODEL 295 ELECTRONIC RESPIROMETER
K903674 · BZK
National Medical Sales, Inc.
Anesthesiology · 144d
Cleared Jan 04, 1991
C FIT CUP
K903938 · JDI
Orthopedic Systems, Inc.
Orthopedic · 130d
Cleared Jan 04, 1991
A2J TELEMETER
K904127 · IWE
A2j, Inc.
Radiology · 128d
Cleared Jan 04, 1991
STARCAM 4000
K904174 · IYX
General Electric Co.
Radiology · 116d
Cleared Jan 04, 1991
BIOPRO TRINITY ACETABULAR CUP
K904207 · JDI
Biopro, Inc.
Orthopedic · 114d
Cleared Jan 04, 1991
ELECTROSURGICAL PENCIL
K904808 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 72d
Cleared Jan 04, 1991
TRANSDUCER PROTECTOR
K904912 · FIB
Filtertek, Inc.
Gastroenterology & Urology · 65d
Cleared Jan 04, 1991
VARIOUS AFTERLOADING APPLICATORS
K904933 · IWJ
Best Assoc. Corp.
Radiology · 64d
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