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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
166009–166032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1980
FINGER, HAND & WRIST EXERCISER
K801453 · ION
Robert W. Slack
Physical Medicine · 41d
Cleared Aug 04, 1980
SPAN-AID BRIDGING PILLOW SYSTEM
K801518 · HKX
Span-America Medical Systems, Inc.
Ophthalmic · 34d
Cleared Aug 04, 1980
KERR CORE COMPOSITE
K801529 · EBF
Sybron Corp.
Dental · 33d
Cleared Aug 04, 1980
STERILE CAST PADDING
K801554 · HIX
Medi-Spec
Ophthalmic · 27d
Cleared Aug 04, 1980
COMPACT MODEL 360 GALVANIC EPILATOR
K801555 · KCW
Associated Electrolysis Group
General & Plastic Surgery · 27d
Cleared Aug 04, 1980
SURG-ASSIST
K801572 · FWZ
Medmetric Corp.
General & Plastic Surgery · 26d
Cleared Aug 04, 1980
AUTO SUTURE DISP. 30, ETC. & SURG. STAP
K801589 · FHM
United States Surgical, A Division of...
General & Plastic Surgery · 24d
Cleared Aug 04, 1980
AUTO SUTURE DISPOSABLE GIA SURG. STAPLER
K801590 · FHM
United States Surgical, A Division of...
General & Plastic Surgery · 24d
Cleared Aug 04, 1980
PFT CALIBRATOR
K801597 · BZC
Spital Medical, Inc.
Anesthesiology · 41d
Cleared Aug 04, 1980
PATHFINDER ELECTRODIAGNOSTIC SYSTEM
K801604 · GWK
Nicolet Biomedical Instruments
Neurology · 21d
Cleared Aug 04, 1980
CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR
K801610 · GCZ
Edward Weck, Inc.
General & Plastic Surgery · 20d
Cleared Aug 04, 1980
DEEP BALFOUR BLADE FOR WILKINSON RETRACT
K801611 · GAD
Edward Weck, Inc.
General & Plastic Surgery · 20d
Cleared Aug 04, 1980
FRAZIER-FERGUSON SUCTION TUBES (DISP.)
K801612 · GCY
Edward Weck, Inc.
General & Plastic Surgery · 20d
Cleared Aug 04, 1980
NON-CONDUCTIVE SHOE COVERS
K801616 · FXP
Procter & Gamble Mfg. Co.
General Hospital · 20d
Cleared Aug 04, 1980
CONDUCTIVE SHOE COVERS
K801617 · FXP
Procter & Gamble Mfg. Co.
General Hospital · 20d
Cleared Aug 04, 1980
MIST2GEN TEMPTROL 10
K801619 · BTT
Mistogen Equipment Co.
Anesthesiology · 20d
Cleared Aug 04, 1980
THE BELLCO FISTULA NEEDLES
K801632 · FIE
Bellco Artifidial Organ Spec., Inc.
Gastroenterology & Urology · 20d
Cleared Aug 04, 1980
BIOBRANE BRAND TEMPORARY WOUND-DRESSING
K801635 · FRO
Hall-Woodroof, Inc.
General & Plastic Surgery · 20d
Cleared Aug 04, 1980
DESERET EMBOLECTOMY/THROMBECTOMY CATH.
K801650 · DXE
Deseret Medical, Inc.
Cardiovascular · 17d
Cleared Aug 04, 1980
NDI-IKE EMG
K801670 · GWK
Neurodiagnostics, Inc.
Neurology · 13d
Cleared Aug 04, 1980
ESG-1 (EVOKED RESPONSE STIMULUS GENER)
K801671 · GWE
Neurodiagnostics, Inc.
Neurology · 13d
Cleared Aug 04, 1980
BETA-CAP II ADAPTER
K801680 · GCE
Quinton, Inc.
General & Plastic Surgery · 13d
Cleared Aug 04, 1980
SPACELINE HIGH VOLUME EVACUATION HANDPIE
K801682 · EHZ
Pacific Dental Corp.
Dental · 14d
Cleared Aug 04, 1980
LUNA-VUE DENTAL OPERATING LIGHT
K801683 · EAZ
Pacific Dental Corp.
Dental · 14d