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
76681–76704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2001
ULTRASAFE DENTAL INJECTION SYSTEM
K013801 · MEG
Safety Syringes, Inc.
General Hospital · 28d
Cleared Dec 13, 2001
MEDRAD QWIK-FIT SYRINGE
K013815 · DXT
Medrad, Inc.
Cardiovascular · 27d
Cleared Dec 13, 2001
IMMUNO-TROL LOW CELLS
K013842 · JPK
Beckman Coulter, Inc.
Hematology · 23d
Cleared Dec 13, 2001
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
K013935 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 15d
Cleared Dec 13, 2001
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84)...
K013992 · CEW
Nichols Institute Diagnostics
Chemistry · 9d
Cleared Dec 12, 2001
BIOSPEED
K013069 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 90d
Cleared Dec 12, 2001
JAMSHIDI BIOPSY NEEDLE
K013070 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 90d
Cleared Dec 12, 2001
SECURCUT ASPIRATION BIOPSY NEEDLE
K013071 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 90d
Cleared Dec 12, 2001
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
K013076 · LEH
Beckman Coulter, Inc.
Toxicology · 89d
Cleared Dec 12, 2001
SAS STREPALERT
K013379 · GTY
Sa Scientific, Inc.
Microbiology · 61d
Cleared Dec 12, 2001
PULPDENT CAVITY PREPARATION IV
K013411 · LBH
Pulpdent Corp.
Dental · 58d
Cleared Dec 12, 2001
MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS
K013423 · JWY
Dade Microscan, Inc.
Microbiology · 71d
Cleared Dec 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE
K013580 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 44d
Cleared Dec 12, 2001
SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN,...
K013767 · FRN
Sterling Medivations, Inc.
General Hospital · 29d
Cleared Dec 12, 2001
MICROJET QUARK, MODEL U100 OR U40
K013807 · LZG
Cane S.R.L.
General Hospital · 27d
Cleared Dec 11, 2001
KNIGHTSTAR 330 VENTILATOR
K003075 · MNT
Mallinckrodt, Inc.
Anesthesiology · 434d
Cleared Dec 11, 2001
SONDREX P.A.L. SYSTEM
K010388 · HCC
Ohmeda Medical
Neurology · 306d
Cleared Dec 11, 2001
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH...
K010443 · DTZ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 300d
Cleared Dec 11, 2001
H.M.T. ACUPUNCTURE NEEDLE
K012501 · MQX
Hummingbird Medical Technology, LLC
General Hospital · 130d
Cleared Dec 11, 2001
ACUGLIDE BRAND ACUPUNCTURE NEEDLES
K012583 · MQX
Helio Medical Supplies, Inc.
General Hospital · 123d
Cleared Dec 11, 2001
RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE...
K012587 · KNS
Vidamed, Inc.
Gastroenterology & Urology · 123d
Cleared Dec 11, 2001
MJS POSTERIOR STABILIZED KNEE SYSTEM
K012762 · HRY
Osteoimplant Technology, Inc.
Orthopedic · 116d
Cleared Dec 11, 2001
GRIP LOCK ANCHOR, MODEL 411374
K013063 · GZB
Medtronic Neurological
Neurology · 90d
Cleared Dec 11, 2001
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K013066 · MND
Olympus America, Inc.
Gastroenterology & Urology · 90d