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
111481–111504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 1993
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K932344 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 164d
Cleared Oct 25, 1993
AIRCAST VENAFLOW SYSTEM
K932900 · JOW
Aircast, Inc.
Cardiovascular · 133d
Cleared Oct 25, 1993
AVI MODEL 600 SYRINGE PUMP
K933005 · FRN
3M Health Care, Ltd.
General Hospital · 126d
Cleared Oct 25, 1993
AVI INFUSION PUMPS, ADDITIONAL INTENDED USE
K933006 · FRN
3M Health Care, Ltd.
General Hospital · 126d
Cleared Oct 25, 1993
STABILTUBE
K934117 · BTR
Garrett Medical Products
Anesthesiology · 62d
Cleared Oct 22, 1993
VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM
K920438 · LZF
Via Medical Corp.
General Hospital · 627d
Cleared Oct 22, 1993
EDENTEC MODEL 3710 I DIGITAL PRINTER
K921819 · BZQ
Edentec Corp.
Anesthesiology · 555d
Cleared Oct 22, 1993
MITEK LIGAMENT ANCHOR
K926270 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 308d
Cleared Oct 22, 1993
CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING
K926299 · MEH
Depuy, Inc.
Orthopedic · 312d
Cleared Oct 22, 1993
READAR
K930478 · LRG
Alamar Biosciences, Inc.
Microbiology · 266d
Cleared Oct 22, 1993
AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY
K930595 · JWH
Orthomet, Inc.
Orthopedic · 259d
Cleared Oct 22, 1993
GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE
K930950 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 241d
Cleared Oct 22, 1993
PROGESTERONE RADIOIMMUNOASSAY KIT
K931228 · JLS
Immunotech Corp.
Chemistry · 226d
Cleared Oct 22, 1993
AIA-PACK(R) PROG ASSAY
K933269 · JLS
Tosoh Medics, Inc.
Chemistry · 108d
Cleared Oct 22, 1993
KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT
K933329 · JMO
King Diagnostics, Inc.
Chemistry · 106d
Cleared Oct 22, 1993
STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
K933464 · CHP
Baxter Diagnostics, Inc.
Chemistry · 98d
Cleared Oct 22, 1993
SIGMA ELECTROLYTE BUFFER
K933695 · JFL
Sigma Chemical Co.
Chemistry · 85d
Cleared Oct 22, 1993
VISTA FOLATE ASSAY
K934121 · CGN
Syva Co.
Chemistry · 58d
Cleared Oct 21, 1993
MEDAC SYSTEM/3
K914925 · HCC
Davicon, Inc.
Neurology · 717d
Cleared Oct 21, 1993
TSA 2001 THERMAL SENSORY ANALYZER
K922052 · LQW
Medoc Corp.
Neurology · 535d
Cleared Oct 21, 1993
SURVALENT II ORAL THERMOMETER
K923289 · FLL
Epson America, Inc.
General Hospital · 472d
Cleared Oct 21, 1993
SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS
K923988 · BZG
Sensor Medics Corp.
Anesthesiology · 437d
Cleared Oct 21, 1993
ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD
K924388 · LDF
Angemed, Inc.
Cardiovascular · 416d
Cleared Oct 21, 1993
SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE
K931185 · CCC
Optical Sensors, Inc.
Anesthesiology · 226d