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
118657–118680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1991
HEMAGEN ENA SCREENING KIT (EIA METHOD)
K915058 · LLL
Hemagen Diagnostics, Inc.
Immunology · 42d
Cleared Dec 20, 1991
HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)
K915234 · LLL
Hemagen Diagnostics, Inc.
Immunology · 28d
Cleared Dec 20, 1991
SPORTS HEAT WRAP
K915241 · IRT
Conair Corp.
Physical Medicine · 37d
Cleared Dec 20, 1991
TOUCH N TONE 1 MASSAGER
K915242 · IRO
Conair Corp.
Physical Medicine · 37d
Cleared Dec 20, 1991
THE BODY BUGGY
K915361 · LYG
Innova Corp.
Physical Medicine · 23d
Cleared Dec 20, 1991
SERENA WHEELCHAIR CUSHIONS
K915368 · KNN
A & C Medical Supply
Physical Medicine · 23d
Cleared Dec 19, 1991
BRANEMARK SYSTEM-3.0MM FIXTURE
K911960 · DZE
Nobelpharma USA, Inc.
Dental · 231d
Cleared Dec 19, 1991
AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS
K912588 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 190d
Cleared Dec 19, 1991
WILDE AUXILIARIES
K912991 · EBI
Wilde-USA, Inc.
Dental · 164d
Cleared Dec 19, 1991
NUCLEOTOME TISSUE ASPIRATOR/CUTTER
K913145 · HRX
Surgical Dynamics, Inc.
Orthopedic · 156d
Cleared Dec 19, 1991
CHRYS XX CO2 SURGICAL LASER SYSTEM
K913606 · GEX
Jamar Medical Systems
General & Plastic Surgery · 127d
Cleared Dec 19, 1991
SEQUENCER
K913612 · IYE
Impac Medical Systems, Inc.
Radiology · 127d
Cleared Dec 19, 1991
HOLMED HAND HELD INSTRUMENTS
K913810 · GCJ
Performance Surgical Instruments Corp.
General & Plastic Surgery · 115d
Cleared Dec 19, 1991
NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER
K914282 · HRX
Surgical Dynamics, Inc.
Orthopedic · 86d
Cleared Dec 19, 1991
K.D. CHIN IMPLANT
K914297 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 85d
Cleared Dec 19, 1991
PROVIDER APM INFUSION PUMP
K914349 · FRN
Abbott Laboratories
General Hospital · 83d
Cleared Dec 19, 1991
MASK, SURGICAL, DISPOSABLE
K914412 · FXX
Industries For the Blind
General Hospital · 79d
Cleared Dec 19, 1991
KODAK EKTASCAN 1120 LASER PRINTER
K914582 · LMC
Eastman Kodak Company
Radiology · 64d
Cleared Dec 19, 1991
MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE
K914758 · GDC
Mdt Corp., Inc.
General & Plastic Surgery · 58d
Cleared Dec 19, 1991
OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR
K914776 · JFC
Talley Group, Ltd.
Physical Medicine · 57d
Cleared Dec 19, 1991
TALLEY SD.500 SKIN PRESSURE EVALUATOR
K914780 · IKE
Talley Group, Ltd.
Physical Medicine · 57d
Cleared Dec 19, 1991
MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST
K914974 · DPS
Medtronic Vascular
Cardiovascular · 43d
Cleared Dec 19, 1991
CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW
K915187 · HWC
Techmedica, Inc.
Orthopedic · 31d
Cleared Dec 19, 1991
CAT-250B
K915413 · IZZ
Toshiba America Medical Systems, In.C
Radiology · 15d