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
119809–119832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 1991
LM-300TWIN
K913135 · FSW
Leisegang Medical, Inc.
General & Plastic Surgery · 64d
Cleared Sep 18, 1991
PALMER ARCH SUPPRESSOR
K913347 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 54d
Cleared Sep 18, 1991
QUALITONE 46PP-AGC-I
K913592 · ESD
Qualitone
Ear, Nose, Throat · 37d
Cleared Sep 18, 1991
ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28
K913707 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Sep 18, 1991
ELEGANCE - KED, BEHIND THE EAR HEARING AID
K913771 · ESD
Qualitone
Ear, Nose, Throat · 27d
Cleared Sep 18, 1991
QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID
K913781 · ESD
Qualitone
Ear, Nose, Throat · 34d
Cleared Sep 18, 1991
URINE THC DIRECT RIA KIT (I-125)
K913865 · LAT
Immunalysis Corporation
Toxicology · 22d
Cleared Sep 17, 1991
HEARING CHECKER(TM), DESKTOP MODEL
K904622 · EWO
Qualitone Hearing Aids and Audiometers
Ear, Nose, Throat · 341d
Cleared Sep 17, 1991
MEDI-KLEER
K904871 · OCT
North American Marketing Corp.
Gastroenterology & Urology · 323d
Cleared Sep 17, 1991
LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR
K905747 · HGI
Coopervision Surgical
Obstetrics & Gynecology · 267d
Cleared Sep 17, 1991
ECHOMARK CSI INTERFACE
K910965 · LIT
Catheter Sciences Co.
Radiology · 195d
Cleared Sep 17, 1991
RICH-MAR MODEL 25 ULTRASOUND
K912202 · IMI
Rich-Mar Corp.
Physical Medicine · 120d
Cleared Sep 16, 1991
MEDRAD VARIBLE INFUSION INJECTOR
K905819 · DXT
Medrad, Inc.
Radiology · 259d
Cleared Sep 16, 1991
THE BULLION
K910757 · KPR
Octostop, Inc.
Radiology · 252d
Cleared Sep 16, 1991
STERILE SURGICAL GOWN PACK
K911131 · KKX
Central Georgia Ancillary Health Systems
General Hospital · 186d
Cleared Sep 16, 1991
TIN COATED DENTAL BURS
K911208 · EJL
Surgical Precision Instruments, Corp.
Dental · 181d
Cleared Sep 16, 1991
RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE
K911433 · JXG
Cordis Corp.
Neurology · 167d
Cleared Sep 16, 1991
ADVANCE DISPOSABLE CONTROL SYRINGE
K911732 · IZI
Advance Medical Designs, Inc.
Radiology · 152d
Cleared Sep 16, 1991
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
K912442 · LYR
Quidel Corp.
Microbiology · 105d
Cleared Sep 16, 1991
CLASSIC 4-WAY ELEVATING TABLE
K912474 · IZZ
Continental X-Ray Corp.
Radiology · 105d
Cleared Sep 16, 1991
GULL ELISAWARE
K912558 · LIB
Gull Laboratories, Inc.
Microbiology · 97d
Cleared Sep 16, 1991
CORDIS INFLATOR DEVICE
K912644 · MAV
Cordis Corp.
Cardiovascular · 91d
Cleared Sep 16, 1991
ENDOSCOPIC ELECTRODE
K912656 · GEI
Applied Urology, Inc.
General & Plastic Surgery · 91d
Cleared Sep 16, 1991
NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT
K912663 · JWH
Intermedics Orthopedics
Orthopedic · 90d