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
97201–97224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 1996
OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER
K961274 · JJE
Olympus America, Inc.
Chemistry · 94d
Cleared Jul 05, 1996
DURACON INSET PATELLA WITH CENTRAL PEG
K961482 · JWH
Howmedica Corp.
Orthopedic · 78d
Cleared Jul 05, 1996
ETEST SUBMISSION FOR CEFOTETAN
K961517 · JWY
Ab Biodisk
Microbiology · 74d
Cleared Jul 05, 1996
ETEST SUBMISSION FOR AZITHROMYCIN
K961519 · JWY
Ab Biodisk
Microbiology · 74d
Cleared Jul 05, 1996
ALLIANCE 2690 SEPARATIONS MODULE
K961557 · LDM
Waters Corporation
Toxicology · 74d
Cleared Jul 05, 1996
THE WAND
K961648 · EJI
Spintech, Inc.
Dental · 67d
Cleared Jul 05, 1996
SPUNCRIT (MODEL DRC-40)
K961803 · GKG
Micro Diagnostics Corp.
Hematology · 57d
Cleared Jul 05, 1996
KARL STORZ TWIN TRANSILLUMINATOR
K962032 · MQW
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 42d
Cleared Jul 05, 1996
SPECIMEN RETRIEVAL BAG
K962395 · GCJ
Applied Medical Resources
General & Plastic Surgery · 15d
Cleared Jul 05, 1996
LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
K962432 · JJX
Clinical Controls, Inc.
Chemistry · 11d
Cleared Jul 03, 1996
FRESENIUS BLOOD TEMPERATURE MONITOR
K941460 · MQS
Fresenius USA, Inc.
Gastroenterology & Urology · 831d
Cleared Jul 03, 1996
SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
K954737 · HCC
J-Tech, Inc.
Neurology · 261d
Cleared Jul 03, 1996
ADVANTAGE WINDOWS WITH FUNCTOOL OPTION
K960265 · LLZ
GE Medical Systems
Radiology · 167d
Cleared Jul 03, 1996
STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771
K960391 · FPA
Strato/Infusaid, Inc.
General Hospital · 156d
Cleared Jul 03, 1996
SCIMED DISPATCH GOLD CORONARY CATHETER
K961294 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Jul 03, 1996
CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES
K961339 · MQX
Helio Medical Supplies, Inc.
General Hospital · 86d
Cleared Jul 03, 1996
MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS
K961366 · LNH
Mri Devices Corp.
Radiology · 85d
Cleared Jul 03, 1996
MANAN PROSTATE LOCKING INTRODUCER SET
K961377 · IWJ
Manan Medical Products, Inc.
Radiology · 84d
Cleared Jul 03, 1996
LIFE IMAGING SYSTEMS LIS 6000 A
K961403 · LLZ
Life Imaging Systems, Inc.
Radiology · 83d
Cleared Jul 03, 1996
DICOMNET
K961451 · IZI
Lockheed Martin Communications Systems
Radiology · 78d
Cleared Jul 03, 1996
SELECT/SP
K961464 · JAK
Elscint, Inc.
Radiology · 77d
Cleared Jul 03, 1996
MICROSPAN HYSTEROSCOPE SHEATH
K961506 · HIH
Imagyn Medical, Inc.
Obstetrics & Gynecology · 75d
Cleared Jul 03, 1996
MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES
K961632 · KGO
Johnson & Johnson Medical, Inc.
General Hospital · 65d
Cleared Jul 03, 1996
PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL)
K961637 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 65d