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
99097–99120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1996
AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)
K953968 · HWE
Aesculap, Inc.
Orthopedic · 167d
Cleared Feb 05, 1996
SIEMENS SC 9000 ETCO2 MODULE
K954632 · CCK
Siemens Medical Solutions USA, Inc.
Anesthesiology · 122d
Cleared Feb 05, 1996
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION)
K954727 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 143d
Cleared Feb 05, 1996
CANDELA CRYO-PROBE HOLDER
K954872 · GEH
Candela Laser Corp.
General & Plastic Surgery · 104d
Cleared Feb 05, 1996
PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)
K954898 · GGT
Genzyme Corp.
Hematology · 138d
Cleared Feb 05, 1996
SORBIE TOTAL ELBOW SYSTEM
K955099 · JDB
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Feb 05, 1996
3M NO STING BARRIER FILM
K955103 · KMF
3M Medical Products Group
General & Plastic Surgery · 89d
Cleared Feb 05, 1996
LYPHOCHEK BENZO/TCA CONTROL-SET B
K955153 · DIF
Bio-Rad
Toxicology · 84d
Cleared Feb 05, 1996
SYNTHETIC SPONGE
K955165 · EFQ
Igenics, Inc.
General & Plastic Surgery · 84d
Cleared Feb 05, 1996
FMS ARTHOPROBE
K955500 · HRX
Future Medical Systems, Inc.
Orthopedic · 66d
Cleared Feb 05, 1996
QBC ACCUREAD SYSTEM
K955504 · GKZ
Becton Dickinson Diagnostic...
Hematology · 66d
Cleared Feb 05, 1996
GENERAL USE SYNTHETIC SPONGE (STERILE)
K955527 · EFQ
Igenics, Inc.
General & Plastic Surgery · 63d
Cleared Feb 05, 1996
ACCESS PROGESTERONE ASSAY
K955769 · JLS
Bio-Rad Laboratories, Inc.
Chemistry · 46d
Cleared Feb 02, 1996
VARIAN MULTILEAF COLLIMATOR
K943224 · IYE
Varian Assoc., Inc.
Radiology · 577d
Cleared Feb 02, 1996
OPTUS OTOSCOPES
K945264 · ERA
Optus, Inc.
Ear, Nose, Throat · 462d
Cleared Feb 02, 1996
PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE...
K951246 · FLS
Protocol Systems, Inc.
Anesthesiology · 319d
Cleared Feb 02, 1996
BRAINLAB STEROTATIC HEADRING
K952390 · HAW
Brainlab Med. Computersysteme GmbH
Neurology · 256d
Cleared Feb 02, 1996
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE
K953564 · DTL
Medtronic Cardiac Surgery, Medtronic,...
Cardiovascular · 186d
Cleared Feb 02, 1996
TEE PROBE
K953579 · ITX
Biosound, Inc.
Radiology · 185d
Cleared Feb 02, 1996
JPI INTENSIFYING SCREEN
K954161 · EAM
Jpi Healthcare Co, Ltd.
Radiology · 150d
Cleared Feb 02, 1996
HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES
K954294 · IXJ
Thermotrex Corp.
Radiology · 141d
Cleared Feb 02, 1996
CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE
K954934 · GEX
Candela Laser Corp.
General & Plastic Surgery · 98d
Cleared Feb 02, 1996
SAS SALMONELLA H Z29 ANTISERUM
K955186 · GNC
Sa Scientific, Inc.
Microbiology · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H Z4, Z23 ANTISERUM
K955187 · GNC
Sa Scientific, Inc.
Microbiology · 80d