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
106441–106464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1994
SOMATOM PROJECT 059
K941546 · JAK
Siemens Corp.
Radiology · 173d
Cleared Sep 20, 1994
KT2000 KNEE LIGAMENT ARTHROMETER
K942059 · LYH
Medmetric Corp.
Neurology · 144d
Cleared Sep 20, 1994
P.F.C. CEMENT RESTRICTOR
K942060 · LZN
Johnson & Johnson Professionals, Inc.
Orthopedic · 144d
Cleared Sep 20, 1994
GAMMA-BCT INTACT PTH
K942369 · CEW
Immunodiagnostic Systems , Ltd.
Chemistry · 125d
Cleared Sep 20, 1994
UC QIK 1-STEP HCG TEST
K942464 · JHI
Eucardio Laboratory, Inc.
Chemistry · 119d
Cleared Sep 20, 1994
INTEGRAL CO-CR FEMORAL COMPONENT
K942479 · JDG
Biomet, Inc.
Orthopedic · 118d
Cleared Sep 20, 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS
K942619 · LFM
Syva Co.
Chemistry · 117d
Cleared Sep 20, 1994
ACETABULAR DOME HOLE PLUGS
K942809 · JDL
Osteonics Corp.
Orthopedic · 98d
Cleared Sep 20, 1994
CROSSFIRE(TM) (705-10650)
K943171 · GEX
Cardiogenes
General & Plastic Surgery · 96d
Cleared Sep 20, 1994
THE YELLOW IRIS
K943463 · KQO
Intl. Remote Imaging Systems
Chemistry · 64d
Cleared Sep 20, 1994
AURATEK FDP
K943787 · DAP
Organon Teknika Corp.
Hematology · 48d
Cleared Sep 20, 1994
CREATININE-PO REAGENT KIT
K943924 · CGX
Synermed, Inc.
Chemistry · 39d
Cleared Sep 20, 1994
FORCEPS, SURGICAL GYNECOLOGICAL
K944055 · HCZ
Owens Precision Systems, Inc.
Obstetrics & Gynecology · 32d
Cleared Sep 20, 1994
KARL STORZ FLUID LIGHT CABLES
K944224 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 21d
Cleared Sep 20, 1994
AUTO SUTURE* ANTI-FOG DEVICE**
K944249 · FEB
United States Surgical, A Division of...
General Hospital · 21d
Cleared Sep 19, 1994
STERI-OSS TITANIUM PLASMA SPRAY SERIES IMPLANT
K925481 · DZE
Steri-Oss, Inc.
Dental · 689d
Cleared Sep 19, 1994
STERI-OSS THREADED TPS HEX SERIES IMPLANT
K925555 · DZE
Steri-Oss, Inc.
Dental · 685d
Cleared Sep 19, 1994
VITAL-PORT VASC ACCESS SYS W/DUAL LUM INJECTROL CA
K932411 · LJT
Med Institute, Inc.
General Hospital · 489d
Cleared Sep 19, 1994
POWDER FREE EXAMINATION GLOVES
K932550 · LYY
Unigloves , Ltd.
General Hospital · 481d
Cleared Sep 19, 1994
DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA
K935254 · GIZ
American Diagnostica, Inc.
Hematology · 322d
Cleared Sep 19, 1994
EXAMINATION GLOVES, POWDER FREE
K935384 · LYY
Jf Trading Co., Ltd.
General Hospital · 315d
Cleared Sep 19, 1994
REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG
K935975 · JTN
Remel, Inc.
Microbiology · 280d
Cleared Sep 19, 1994
DISPOSABLE MICROSTAAR INJECTOR
K940593 · KYB
Staar Sugical
Ophthalmic · 222d
Cleared Sep 19, 1994
PIONEER LABORATORIES CABLE PIN
K941174 · HWC
Pioneer Surgical Technology
Orthopedic · 189d