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
117313–117336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1992
ENZYGNOST(R) ANTI-CMV IGG
K913910 · LFZ
Behring Diagnostics, Inc.
Microbiology · 242d
Cleared Apr 28, 1992
CORRECTED-V.P.S.
K914178 · ELW
Jeneric/Pentron, Inc.
Dental · 223d
Cleared Apr 28, 1992
ELECTROSURGICAL GENERATOR MODEL ESU100/250/550
K914367 · HGI
Gyne-Tech Instrument Corp.
Obstetrics & Gynecology · 210d
Cleared Apr 28, 1992
PH METER, MODIFICATION
K914624 · FFT
Synectics-Dantec
Gastroenterology & Urology · 195d
Cleared Apr 28, 1992
SCHWABE RADIUS PLATES
K914803 · HRS
Link America, Inc.
Orthopedic · 187d
Cleared Apr 28, 1992
THERAPEUTIC STIMULATOR 2100 (TS-2100)
K914904 · IPF
Myo/Kinetic Systems, Inc.
Physical Medicine · 179d
Cleared Apr 28, 1992
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
K915358 · KGX
Medtronic Vascular
General & Plastic Surgery · 153d
Cleared Apr 28, 1992
MRT-50 MULTIVIEW COIL
K920095 · LNH
Toshiba America Mri, Inc.
Radiology · 111d
Cleared Apr 28, 1992
EPISCOPE, MODEL 47300
K920103 · KZF
Welch Allyn, Inc.
General Hospital · 110d
Cleared Apr 28, 1992
GX-C CEPHALOMETER
K920189 · EAG
Gendex Corp.
Radiology · 104d
Cleared Apr 28, 1992
MORTARA INSTRUMENT MODEL ECG PREVU
K920377 · LOS
Mortara Instrument, Inc.
Cardiovascular · 90d
Cleared Apr 28, 1992
4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL
K920460 · ELL
Pulpdent Corp.
Dental · 92d
Cleared Apr 28, 1992
14% HYDROFLUORIC ACID ETCHING GEL
K920482 · EBF
Pulpdent Corp.
Dental · 89d
Cleared Apr 28, 1992
2.5% NITRIC ACID ETCHING GEL
K920484 · EBF
Pulpdent Corp.
Dental · 89d
Cleared Apr 28, 1992
TRUE/FLEX HUMERUS CAP
K920598 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 77d
Cleared Apr 28, 1992
PHOENIX STERI-TECH STERILE DENTAL PACK GEN-10001
K920682 · FXX
Phoenix Steri-Tech, Inc.
General Hospital · 74d
Cleared Apr 28, 1992
JENKER NEEDLE STICK PROTECTOR
K920758 · DZM
Dentsply Intl.
Dental · 69d
Cleared Apr 28, 1992
DECOMPRESSION TUBES
K920894 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 67d
Cleared Apr 28, 1992
SILICONT BUR BLOCK
K921406 · EJL
Innovators, Inc.
Dental · 39d
Cleared Apr 28, 1992
RIONET HEARING AID HB-52T
K921830 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 12d
Cleared Apr 27, 1992
ACCUSCOPE(TM) & ACCUSCOPE II(TM)
K913365 · HEX
Vineland Medical Products, Inc.
Obstetrics & Gynecology · 273d
Cleared Apr 27, 1992
ESCORT-LINK ARRHYTHMIA OPTION 23L
K915153 · DSI
Medical Data Electronics
Cardiovascular · 165d
Cleared Apr 27, 1992
COROMETRICS MODEL 150 FETAL MONITOR
K920376 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 89d
Cleared Apr 27, 1992
ECAT EXACT HR MODEL 961
K920624 · KPS
Cti Pet Systems, Inc.
Radiology · 76d