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
147481–147504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1985
EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT)
K851331 · BXB
Empi
Physical Medicine · 104d
Cleared Jul 17, 1985
SONOMED 4
K851937 · IMI
Robert Bosch Corp.
Physical Medicine · 93d
Cleared Jul 17, 1985
SUPRIMA II MODEL 253-23
K852430 · DXY
Intermedics, Inc.
Cardiovascular · 37d
Cleared Jul 17, 1985
SUPRIMA II MODEL 254-28
K852432 · DXY
Intermedics, Inc.
Cardiovascular · 37d
Cleared Jul 16, 1985
ISOGEL AGAROSE
K841407 · JJN
Fmc Corp.
Chemistry · 468d
Cleared Jul 16, 1985
MEDTRONIC 5311 PACING SYSTEM ANALYZER
K850077 · DTC
Medtronic Vascular
Cardiovascular · 188d
Cleared Jul 16, 1985
CHRONOCOR V EXTERNAL PACER, MODEL 297A
K850822 · DTE
Seamed Corp.
Cardiovascular · 138d
Cleared Jul 16, 1985
VASCULAR IMPLANT ACCESS NEEDLE SET
K851103 · FMI
Baxter Healthcare Corp
General Hospital · 119d
Cleared Jul 16, 1985
CEMENTRIFUGE
K851205 · JDZ
Biodynamic Technologies, Inc.
Orthopedic · 112d
Cleared Jul 16, 1985
HEMOGLOBIN ANALYZER
K851467 · KHG
Awareness Technology, Inc.
Hematology · 92d
Cleared Jul 16, 1985
BIO-CHALLENGE TEST PAK
K851804 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 77d
Cleared Jul 16, 1985
THE P.C.A. DOME PATELLA COMPONENT
K852059 · JWH
Howmedica Corp.
Orthopedic · 68d
Cleared Jul 16, 1985
INTRAVENOUS INJECTION SET
K852361 · FPA
The West Co., Inc.
General Hospital · 42d
Cleared Jul 16, 1985
TIMENTIN 85MCG SENSITIVITY DISC
K852423
Difco Laboratories, Inc.
Microbiology · 39d
Cleared Jul 16, 1985
STRYKER 988 ICU BED
K852674 · FNL
Stryker Corp.
General Hospital · 22d
Cleared Jul 15, 1985
EDENTEC MODEL 2000W APNEA MONITOR
K844327 · BZQ
Edentec Corp.
Anesthesiology · 250d
Cleared Jul 15, 1985
MEC DISTAL FEMORAL BOLT
K850403 · KTT
Pfizer, Inc.
Orthopedic · 164d
Cleared Jul 15, 1985
MEC HIP BOLT
K850413 · KTT
Pfizer, Inc.
Orthopedic · 161d
Cleared Jul 15, 1985
MEC ROD CONNECTOR
K850443 · KTT
Pfizer, Inc.
Orthopedic · 160d
Cleared Jul 15, 1985
HOWMEDICA THREADED ACETABULAR COMPONENT
K850840 · KWA
Pfizer, Inc.
Orthopedic · 136d
Cleared Jul 15, 1985
REGIONAL ANESTHESIA TRAYS
K851134 · CAZ
Concord Laboratories, Inc.
Anesthesiology · 116d
Cleared Jul 15, 1985
SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
K851341 · KYK
Depuy, Inc.
Orthopedic · 103d
Cleared Jul 15, 1985
VYGON DELEE SUCTION CATHETER CODE NO 533
K851473 · BSY
Vygon Corp.
Anesthesiology · 91d
Cleared Jul 15, 1985
OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR
K851509 · CBK
Ohmeda Medical
Anesthesiology · 91d