FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94105–94128 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 1997
SH-1 SURGICAL HOLDER FOR TELESCOPE
K960068 · OCV
Olympus America, Inc.
Gastroenterology & Urology · 486d
Cleared May 05, 1997
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
K963054 · LJZ
Genbio
Microbiology · 272d
Cleared May 05, 1997
O'REGAN LIGATOR
K963166 · FHN
Patrick J. O'Regan
Gastroenterology & Urology · 264d
Cleared May 05, 1997
PRESS-FIT HIP STEM
K964178 · LWJ
Encore Orthopedics, Inc.
Orthopedic · 199d
Cleared May 05, 1997
HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES
K964625 · DSY
Intervascular, Inc.
Cardiovascular · 171d
Cleared May 05, 1997
SHADOWFORM
K964972 · KPQ
I.Z.I. Medical Products Corp.
Radiology · 144d
Cleared May 05, 1997
TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE
K965045 · HET
Ethicon Endo-Surgery, Inc.
Obstetrics & Gynecology · 139d
Cleared May 05, 1997
VIDAS ROTAVIRUS ASSAY
K965092 · LIQ
Biomerieux Vitek, Inc.
Microbiology · 137d
Cleared May 05, 1997
BEHRING COAGULATION SYSTEM
K970431 · JPA
Behring Diagnostics, Inc.
Hematology · 90d
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