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
90529–90552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1998
BIOSPECTROMETER-NB OXIMETER IIII
K963903 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 484d
Cleared Jan 27, 1998
N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
K973037 · IWJ
Avid N.I.T., Inc.
Radiology · 166d
Cleared Jan 27, 1998
ACTIVATOR II
K973506 · LXM
Activator Methods, Inc.
Physical Medicine · 133d
Cleared Jan 27, 1998
COBE OXYGENATOR PRODUCTS
K974085 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Jan 27, 1998
X-SIGHT DIGITAL IMAGING SYSTEM
K974134 · LLZ
Stallion Technologies, Inc.
Radiology · 85d
Cleared Jan 27, 1998
ENDOLYMPHATIC SAC TO MASTOID T-SHUNT
K974224 · ESZ
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 78d
Cleared Jan 27, 1998
CD-R STATION AND VRS-2000
K974255 · LMD
Electromed Intl., Ltd.
Radiology · 75d
Cleared Jan 27, 1998
MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY
K974308 · MOS
Medrad, Inc.
Radiology · 71d
Cleared Jan 27, 1998
RUSCH SIMPLASTIC COUNCILL TIP CATHETER
K974419 · EZL
Rusch, Inc.
Gastroenterology & Urology · 64d
Cleared Jan 27, 1998
VIROTROL III
K974613 · JJY
Blackhawk Biosystems, Inc.
Microbiology · 47d
Cleared Jan 27, 1998
PERCUPUMP II WITH EDA
K974621 · DSB
E-Z-Em, Inc.
Radiology · 47d
Cleared Jan 27, 1998
BREEZY SERIES
K974820 · IOR
Sunrise Medical, Inc.
Physical Medicine · 35d
Cleared Jan 27, 1998
NON-PRESCRIPTION SUNGLASSES
K974861 · HQY
Wenzhou Hindar Optical Co., Ltd.
Ophthalmic · 29d
Cleared Jan 26, 1998
HUNTLEIGH FP5000 SYSTEM MODEL FP5000
K965153 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 399d
Cleared Jan 26, 1998
CORONARY VEIN GRAFT TAG MARKER
K971966 · KPK
Med-Edge, Inc.
Cardiovascular · 243d
Cleared Jan 26, 1998
ROSS ENTERAL FEEDING TUBE
K972437 · FPD
Ross Products
Gastroenterology & Urology · 210d
Cleared Jan 26, 1998
PERIO CONTROL II
K972642 · EIK
Estrad B.V.
Dental · 195d
Cleared Jan 26, 1998
RINOFLOW MICRONIZED E.N.T. WASH SYSTEM
K973875 · KMA
Respironics, Inc.
Ear, Nose, Throat · 108d
Cleared Jan 26, 1998
PYRILINKS-D ASSAY KIT
K974260 · JMM
Metra Biosystems, Inc.
Chemistry · 74d
Cleared Jan 26, 1998
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K974451 · CGA
Lifescan, Inc.
Chemistry · 62d
Cleared Jan 26, 1998
QUICKSTICK PRO HCG TEST
K974615 · JHI
Phamatech
Chemistry · 46d
Cleared Jan 26, 1998
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
K974733 · LBR
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Jan 26, 1998
BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
K974821 · LCX
Quidel Corp.
Chemistry · 34d
Cleared Jan 23, 1998
ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)
K965209 · DSP
Arrow Intl., Inc.
Cardiovascular · 392d