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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
148321–148344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1985
SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201
K852279 · JEQ
Northern Electric Co. Div. of Sunbeam...
Dental · 33d
Cleared Jul 01, 1985
INOX THERMOMETER JAR
K852301 · FLK
Broadwest Corp.
General Hospital · 33d
Cleared Jul 01, 1985
PNEUMOSCOPE
K852337 · BZG
Erich Jaeger, Inc.
Anesthesiology · 31d
Cleared Jul 01, 1985
DISTALITE POSTERIA DENTAL RESTORATIVE
K852344 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 28d
Cleared Jul 01, 1985
PLAK SMACKER
K852400 · EFW
Plak Smacker Toothbrush Co.
Dental · 25d
Cleared Jul 01, 1985
UNION BROACH BLEACHING LIGHT
K852474
Union Broach, Div. Moyco Industries,...
Dental · 20d
Cleared Jul 01, 1985
PROPOL DENTAL POLISHING PASTE
K852489 · EJR
Scientific Pharmaceuticals, Inc.
Dental · 24d
Cleared Jul 01, 1985
OHMEDA CPU MONITOR
K852504
Ohmeda Medical
Cardiovascular · 19d
Cleared Jul 01, 1985
ULTRASONIC TOOTH SCALER MODEL DSCIOP
K852540 · ELC
Parkell, Inc.
Dental · 17d
Cleared Jun 28, 1985
CARDIAC EVENT RECORDER
K843533 · DRT
Cryo2 Corp.
Cardiovascular · 294d
Cleared Jun 28, 1985
GORE-TEX TISSUE MATRIX
K844142
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 248d
Cleared Jun 28, 1985
HEALTHMASTER- MODEL 8320 MOTORIZED TREADMILL
K844779 · BXB
Roadmaster Corp.
Physical Medicine · 200d
Cleared Jun 28, 1985
EMIT ANCILLARY REAGENTS
K844947 · KIE
Syva Co.
Toxicology · 190d
Cleared Jun 28, 1985
EMIT AMITRIPTYLINE ASSAY
K844950 · LFG
Syva Co.
Toxicology · 190d
Cleared Jun 28, 1985
EMIT IMIPRAMINE ASSAY
K844951 · LFG
Syva Co.
Toxicology · 190d
Cleared Jun 28, 1985
EMIT NORTRIPTYLINE ASSAY
K844952 · LFG
Syva Co.
Toxicology · 190d
Cleared Jun 28, 1985
EMIT DESIPRAMINE ASSAY
K844953 · LFG
Syva Co.
Toxicology · 190d
Cleared Jun 28, 1985
SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS
K850634 · GCY
Surgidyne, Inc.
General & Plastic Surgery · 129d
Cleared Jun 28, 1985
FLUTED SUCTION MENISCAL CUTTER
K850789 · KIJ
T. Korossurgical Instruments Corp.
Orthopedic · 122d
Cleared Jun 28, 1985
UNIVERSAL POWER FLEX
K851177 · BXB
Biodynamic Technologies, Inc.
Physical Medicine · 95d
Cleared Jun 28, 1985
MOBIE SCOOTER
K851256 · INI
Everest & Jennings, Inc.
Physical Medicine · 92d
Cleared Jun 28, 1985
CRS ULTRALITE PREMIER
K851257 · IOR
Everest & Jennings, Inc.
Physical Medicine · 92d
Cleared Jun 28, 1985
AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE
K851374 · HRX
American Edwards Laboratories
Orthopedic · 81d
Cleared Jun 28, 1985
SEGMENTAL SPINAL RODS
K851414 · KWQ
Stuart
Orthopedic · 80d