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
93601–93624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 1997
ANSPACH LUBRICATING SYSTEM II
K970530 · GEY
The Anspach Effort, Inc.
General & Plastic Surgery · 82d
Cleared May 05, 1997
DISPOSABLE VITRECTOMY PROBE
K970673 · HQE
Altex Vision
Ophthalmic · 70d
Cleared May 05, 1997
MICROSPAN INSEMINATION SYSTEM
K970750 · MFD
Imagyn Medical, Inc.
Obstetrics & Gynecology · 63d
Cleared May 05, 1997
MODIFIED USSC* POLYSORB SUTURE
K970863 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 56d
Cleared May 05, 1997
FIEGERT ENDOTECH CYSTOSCOPE
K970892 · FAJ
Fiegert, Inc.
Gastroenterology & Urology · 55d
Cleared May 05, 1997
MEDILOG FD4
K970902 · DSH
Oxford Instruments Medical Systems
Cardiovascular · 55d
Cleared May 05, 1997
ELECTROSURGICAL ELECTRODE
K970987 · GEI
Fusion Medical Technologies, Inc.
General & Plastic Surgery · 48d
Cleared May 05, 1997
STANDARD & EXTENDED BLADE/NEEDLE/BALL
K971187 · JOS
Aaron Medical Industries
General & Plastic Surgery · 34d
Cleared May 05, 1997
APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
K971498 · EZB
Applied Medical Resources
Gastroenterology & Urology · 10d
Cleared May 02, 1997
AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES
K962807 · HBA
American Surgical Sponges
Neurology · 288d
Cleared May 02, 1997
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
K963055 · LJZ
Genbio
Microbiology · 269d
Cleared May 02, 1997
TRANSMEDICA MODEL 100 DIGITAL ELECTRONIC STETHOSCOPE
K963418 · DQD
Transmedica, Inc.
Cardiovascular · 245d
Cleared May 02, 1997
BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
K963782 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 224d
Cleared May 02, 1997
EBI SPINELINK SYSTEM
K964797 · KWQ
Electro-Biology, Inc.
Orthopedic · 154d
Cleared May 02, 1997
SEALED LEAD ACID BATTERY PACK
K970234 · IZL
Portable Power Systems, Inc.
Radiology · 101d
Cleared May 02, 1997
BONE SOURCE HYDROXYAPATITE
K970400 · LZK
Orthofix, Inc.
General & Plastic Surgery · 88d
Cleared May 02, 1997
PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT
K970490 · LZO
Stelkast Company
Orthopedic · 81d
Cleared May 02, 1997
RIS SCANVIEW SYSTEM (RSVS)
K970641 · LMD
Radiology Information Systems, Inc.
Radiology · 71d
Cleared May 02, 1997
MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE
K970652 · LMD
Mitra Imaging, Inc.
Radiology · 70d
Cleared May 02, 1997
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
K970665 · EPF
Williams Sound, LLC
Ear, Nose, Throat · 70d
Cleared May 02, 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K970676 · JWY
Dade Intl., Inc.
Microbiology · 67d
Cleared May 02, 1997
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
K970687 · EPF
Williams Sound, LLC
Ear, Nose, Throat · 67d
Cleared May 02, 1997
ACPII ANTERIOR CERVICAL PLATE SYSTEM
K970806 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 58d
Cleared May 02, 1997
DIGIT-GRIP WITH LCD (DGR002)
K970870 · HRW
Nk Biotechnical Corp.
Neurology · 53d