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
169513–169536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1979
TOGUARD
K790652 · IPG
Togard, Inc.
Physical Medicine
Cleared Apr 03, 1979
HEALTH POINT
K781651 · BWK
Anritsu America Co.
Neurology · 188d
Cleared Apr 03, 1979
LANCER ICE CUBE
K782077 · JRM
Sherwood Medical Industries
Pathology · 111d
Cleared Apr 03, 1979
ELECTRODES, FERRIS ECG, TYPES 905,906
K790305 · DRX
Ferris Mfg. Corp.
Cardiovascular · 49d
Cleared Apr 03, 1979
ZIMMER SURGICAL INSTRUMENT LUBRICANT
K790331
Zimmer, Inc.
General & Plastic Surgery · 46d
Cleared Apr 03, 1979
LEAD MODELS MUM 1260, MUM 1290
K790386 · DTB
Ela Medical, Inc.
Cardiovascular · 36d
Cleared Apr 03, 1979
TRACH CARE KIT
K790437 · BTO
Abco Dealers, Inc.
Anesthesiology · 27d
Cleared Apr 03, 1979
MODEL 78801A PATIENT MONITORS
K790454 · DRT
Hewlett-Packard Co.
Cardiovascular · 29d
Cleared Apr 03, 1979
A-GENT IMMUNOGLOBULINE TEST SYSTEM
K790479 · CZP
Abbott Laboratories
Chemistry · 26d
Cleared Apr 03, 1979
TULANE HEAT-PACK
K790480 · IMD
Tulane
Physical Medicine · 26d
Cleared Apr 03, 1979
MODEL FS1
K790481 · KHL
Starkey Laboratories, Inc.
Ear, Nose, Throat · 26d
Cleared Apr 03, 1979
MODEL 4107-2S, HEARING AID
K790482 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 26d
Cleared Apr 03, 1979
LISS REAGENT
K790498 · KSG
Fisher Scientific Co., LLC
Hematology · 21d
Cleared Apr 03, 1979
BEHIND-THE-EAR HEARING AID
K790515 · ESD
Danavox, Inc.
Ear, Nose, Throat · 19d
Cleared Apr 03, 1979
HEMATROL S HEMATOLOGY CONTROLS
K790525 · JPK
Fisher Scientific Co., LLC
Hematology · 19d
Cleared Apr 03, 1979
THERAPY GYROSCOPE
K790528 · KNL
Maddak, Inc.
Physical Medicine · 19d
Cleared Apr 03, 1979
WALKING AID
K790529 · ITJ
Maddak, Inc.
Physical Medicine · 19d
Cleared Apr 03, 1979
PUSH BALL INCLINE
K790530 · ION
Maddak, Inc.
Physical Medicine · 19d
Cleared Apr 03, 1979
PRO-TAB
K790547 · KCT
Professional Tape Co., Inc.
General Hospital · 14d
Cleared Apr 03, 1979
CRUTCH
K790557 · IPR
Maddak, Inc.
Physical Medicine · 15d
Cleared Apr 03, 1979
CERSA-CANE
K790558 · IPS
Maddak, Inc.
Physical Medicine · 15d
Cleared Apr 03, 1979
OFFSET ALUMINUM CANE
K790561 · IPS
Maddak, Inc.
Physical Medicine · 15d
Cleared Apr 03, 1979
CANVAS WEDGE
K790587 · IOD
Maddak, Inc.
Physical Medicine · 7d
Cleared Apr 02, 1979
ENDOSCOPE AND ACCESSORIES
K790071 · GCP
Olympus Corp.
Gastroenterology & Urology · 81d