Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
153001–153024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1984
GLATTELAST COMPRESSION PANTY HOSE
K841252 · DWL
Baurs Krey Assoc., Inc.
General Hospital · 93d
Cleared Jun 27, 1984
STELDENT - DENTAL ALLOY
K841290 · EJH
Eriez
Dental · 90d
Cleared Jun 27, 1984
FUZZY TRAY
K841323 · EHY
Buffalo Dental Mfg. Co., Inc.
Dental · 86d
Cleared Jun 27, 1984
OTICON E28A
K841436 · ESD
Oticon Corp.
Ear, Nose, Throat · 82d
Cleared Jun 27, 1984
POLYSULFIDE CUSTOM TRAY MATERIAL
K841490 · ELW
Buffalo Dental Mfg. Co., Inc.
Dental · 78d
Cleared Jun 27, 1984
AUDIOMETER MA728
K841567 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 71d
Cleared Jun 27, 1984
ALINE ORTHODONTIC ARCHWIRE
K841638 · DZC
A Company, Inc.
Dental · 68d
Cleared Jun 27, 1984
FLOSS N' GLOSS/SAFETY FLOSS MED DEVICE
K841675 · JES
Leonard Lorch
Dental · 65d
Cleared Jun 27, 1984
IMR-90-DIPLOID-HUMAN FETAL LUNG CELL
K841998 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 42d
Cleared Jun 27, 1984
MONTGOMERY LARYNGEAL STENT
K842287 · FWN
Boston Medical Products, Inc.
Ear, Nose, Throat · 12d
Cleared Jun 27, 1984
EXACTA-FILM
K842512
Ardent Intl., Inc.
Dental
Cleared Jun 26, 1984
SPIROTECH ST-550
K840972 · BZG
Spirotech, Inc.
Anesthesiology · 112d
Cleared Jun 26, 1984
PULSE GENERATOR 728, 728B & 728L
K841226 · DXY
Siemens Elema AB
Cardiovascular · 96d
Cleared Jun 26, 1984
PULSE GENERATOR 718B & 718L
K841228 · DXY
Siemens Elema AB
Cardiovascular · 96d
Cleared Jun 26, 1984
PULSE GENERATOR 688B & 688L
K841231 · DXY
Siemens Elema AB
Cardiovascular · 96d
Cleared Jun 26, 1984
UNIMACS, PATENT PENDING UNIVERSAL MAM
K841774 · IZH
Technical Devices For Medicine
Radiology · 57d
Cleared Jun 26, 1984
PARA 4
K842017 · JPK
Streck Laboratories, Inc.
Hematology · 39d
Cleared Jun 26, 1984
PARAPLAST EXTRA TISSUE EMBEDDING MED.
K842053 · KEO
Sherwood Medical Co.
Pathology · 35d
Cleared Jun 26, 1984
GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY
K842079 · CGC
Immuno Nuclear Corp.
Chemistry · 34d
Cleared Jun 26, 1984
WAKO B.G. PRETEST STRIPS
K842207 · CGA
Healthdyne, Inc.
Chemistry · 22d
Cleared Jun 26, 1984
MELOY AUTOANTIBODY TEST SYS
K842247 · DBM
Meloy Laboratories, Inc.
Immunology · 20d
Cleared Jun 26, 1984
ZINC DUST SUSPENSION
K842299 · JSF
Irvine Diagnostic Services
Microbiology · 15d
Cleared Jun 26, 1984
CAPNOMETER
K842325 · CCK
Sensors, Inc.
Anesthesiology · 13d
Cleared Jun 26, 1984
PENLON TRANSPORT VENTILATOR SERIES 350
K842362 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 11d