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
87001–87024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 1999
BIOCLOT APC SENSITIVITY
K983898 · GGP
Biopool Intl., Inc.
Hematology · 64d
Cleared Jan 06, 1999
DUAL VIAL CREATININE REAGENT
K983937 · CGX
Intersect Systems, Inc.
Chemistry · 62d
Cleared Jan 06, 1999
MODIFICATION OF TSRH SPINAL SYSTEM
K984522 · MNI
Danek Medical, Inc.
Orthopedic · 16d
Cleared Jan 05, 1999
SYSTEM U3 FOR NITROFURANTOIN
K983565 · JWY
Ab Biodisk
Microbiology · 84d
Cleared Jan 04, 1999
HEWLETT-PACKARD M1205A VIRIDIA 24 CT
K981376 · DSI
Hewlett-Packard Co.
Cardiovascular · 263d
Cleared Jan 04, 1999
STATIM 5000 CASSETTE AUTOCLAVE
K983679 · FLE
Scican
General Hospital · 76d
Cleared Dec 31, 1998
ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS
K981680 · FIP
Dayton Water Systems
Gastroenterology & Urology · 232d
Cleared Dec 31, 1998
INSTATRAK 3000
K983529 · LLZ
Visualization Technology, Inc.
Radiology · 84d
Cleared Dec 31, 1998
'RAPID DRUG SCREEN' 9-PANEL
K983770 · DKZ
American Bio Medica Corp.
Chemistry · 66d
Cleared Dec 31, 1998
DEPUY ACE SPIDER PLATE
K984458 · HRS
Depuy Ace Medical Co.
Orthopedic · 16d
Cleared Dec 30, 1998
MOUNTABLE ENDOSCOPIC KNIFE
K982142 · EMF
A.M. Surgical, Inc.
General & Plastic Surgery · 196d
Cleared Dec 30, 1998
RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC
K982549 · IYE
Radionics, Inc.
Radiology · 162d
Cleared Dec 30, 1998
ROCS TPS
K982791 · MUJ
Radiation Oncology Computer Systems
Radiology · 142d
Cleared Dec 30, 1998
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20,...
K983055 · LIT
Guidant Corp.
Cardiovascular · 120d
Cleared Dec 30, 1998
DIGORA FOR WINDOWS 2.0
K983267 · MUH
Orion Corporation Soredex
Radiology · 104d
Cleared Dec 30, 1998
COMFEEL SEASORB DRESSING
K983519 · KMF
Coloplast Corp.
General & Plastic Surgery · 83d
Cleared Dec 30, 1998
SYSTEM U3 FOR TETRACYCLINE
K983571 · JWY
Ab Biodisk
Microbiology · 78d
Cleared Dec 30, 1998
BODYFORM THORACO-LUMBAR FIXATION SYSTEM
K983622 · KWQ
Theken Surgical,Llc
Orthopedic · 76d
Cleared Dec 30, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II
K983747 · DKB
Beckman Coulter, Inc.
Toxicology · 68d
Cleared Dec 30, 1998
AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5
K983761 · GEI
Aaron Medical Industries
General & Plastic Surgery · 65d
Cleared Dec 30, 1998
SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM
K983873 · KTT
Syntec Scientific Corp.
Orthopedic · 58d
Cleared Dec 30, 1998
METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM
K983976 · JDQ
Metagen, LLC
Orthopedic · 51d
Cleared Dec 30, 1998
ANTERIOR CERVICAL PLATING SYSTEM
K984342 · KWQ
United States Surgical, A Division of...
Orthopedic · 26d
Cleared Dec 30, 1998
DEPUY ACROMED MOSS SPINAL SYSTEM
K984378 · MNI
Depuy, Inc.
Orthopedic · 23d