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
100153–100176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM
K950480 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 276d
Cleared Nov 06, 1995
AVOXIMETER 4000
K951485 · JKS
A-Vox Systems, Inc.
Toxicology · 221d
Cleared Nov 06, 1995
CRYO CHECK LUPUS PLASMA
K952623 · GGC
Precision Biologicals, Inc.
Hematology · 151d
Cleared Nov 06, 1995
SURGICAL INTEGRATED CAMERA SYSTEM
K953438 · GCJ
Envision Medical Corp.
General & Plastic Surgery · 108d
Cleared Nov 06, 1995
LUBINUS SP II HIP SYSTEM
K953653 · JDG
Turnkey Intergration USA, Inc.
Orthopedic · 95d
Cleared Nov 06, 1995
DERRICK SAFETOUCH
K953709 · LYY
M.P.S. Pharm'L Int'L
General Hospital · 89d
Cleared Nov 06, 1995
HUMAN TUBAL FLUID
K953719 · MFD
Life Technologies, Inc.
Obstetrics & Gynecology · 89d
Cleared Nov 06, 1995
SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM
K953778 · MNH
Advanced Spine Fixation Systems, Inc.
Orthopedic · 84d
Cleared Nov 06, 1995
CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5
K953792 · LZO
U.S. Medical Products, Inc.
Orthopedic · 84d
Cleared Nov 06, 1995
KARL STORZ TAKE-APART BIOPOLAR FORCEPS
K953809 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 89d
Cleared Nov 06, 1995
SILCLEAR TUBING (MODIFICATION)
K953864 · FPK
Degania Silicone , Ltd.
General Hospital · 91d
Cleared Nov 06, 1995
KENTEX
K953914 · EFQ
Kentron Health Care, Inc.
General & Plastic Surgery · 77d
Cleared Nov 06, 1995
PERCUTANEOUS DISCECTOMY CANNULA SYSTEM
K954014 · HRX
T. Korossurgical Instruments Corp.
Orthopedic · 73d
Cleared Nov 06, 1995
ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES
K954052 · HRX
T. Korossurgical Instruments Corp.
Orthopedic · 69d
Cleared Nov 06, 1995
BARRAQUER-KRUMEICH REFRACTIVE SET
K954058 · HNO
Eyetech M.V.A.
Ophthalmic · 154d
Cleared Nov 06, 1995
SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP
K954116 · FEW
Technical Products, Inc.
Gastroenterology & Urology · 109d
Cleared Nov 06, 1995
MICRO-INGRESSOR HANDIPIECE
K954796 · ERL
Trebay Medical Corp.
Ear, Nose, Throat · 19d
Cleared Nov 03, 1995
LIP GRIP CAP HOLDER
K935916 · FMI
Daryl C. Fallas
General Hospital · 694d
Cleared Nov 03, 1995
IMEX 8000 PERSONAL CASCULAR LAB
K942243 · IYO
Imex Medical Systems, Inc.
Radiology · 543d
Cleared Nov 03, 1995
FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE...
K945519 · MPG
Pharmaquest Corp.
Chemistry · 359d
Cleared Nov 03, 1995
COMFORT-Q SUBCUTANEOUS INJECTION SETS
K946170 · FOZ
B. Braun of America, Inc.
General Hospital · 319d
Cleared Nov 03, 1995
SYSMEX SF-3000
K950508 · FPK
Sysmex Corp.
Hematology · 270d
Cleared Nov 03, 1995
ACL FUTURA COAGULATION SYSTEM
K951891 · JPA
Instrumentation Laboratory CO
Hematology · 193d
Cleared Nov 03, 1995
PYRILINKS POLYCLONAL ASSAY KIT
K952026 · JMM
Metra Biosystems, Inc.
Chemistry · 186d