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
98161–98184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 1996
NOGA
K960542 · DRF
Biosense, Ltd.
Cardiovascular · 68d
Cleared Apr 15, 1996
NON-CORING NEEDLE
K960698 · FMI
Med Institute, Inc.
General Hospital · 55d
Cleared Apr 15, 1996
HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500
K960732 · GXY
Physiometrix, Inc.
Neurology · 53d
Cleared Apr 15, 1996
FOUNDATION GLENOID COMPONENT
K960906 · KWS
Encore Orthopedics, Inc.
Orthopedic · 41d
Cleared Apr 15, 1996
EXPANDED BODY SUTURE
K961025 · GAT
Medicinelodge, Inc.
General & Plastic Surgery · 32d
Cleared Apr 15, 1996
CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING
K961177 · DWL
Carolina Narrow Fabric Co.
General Hospital · 21d
Cleared Apr 12, 1996
BIOSENSOR BIDOP VASCULAR TEST SYSTEM
K943338 · JAF
Biosensor Corp.
Radiology · 640d
Cleared Apr 12, 1996
SECOND EAR BONE CONDUCTION HEARING AID
K953872 · LXB
Wordcomp International Communication...
Ear, Nose, Throat · 239d
Cleared Apr 12, 1996
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K954353 · LNH
General Electric Co.
Radiology · 207d
Cleared Apr 12, 1996
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K954354 · LNH
General Electric Co.
Radiology · 207d
Cleared Apr 12, 1996
RTI MEDICAL
K954567 · LMD
Radiology Telenetwork Intl.
Radiology · 196d
Cleared Apr 12, 1996
FLOWMATE LTE
K954759 · BZG
Spirometrics Medical Equipment Co.
Anesthesiology · 178d
Cleared Apr 12, 1996
OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM
K955251 · OXO
Imaging Services, Inc.
Radiology · 149d
Cleared Apr 12, 1996
CPR DRESSING CHANGE TRAY
K960206 · FRG
Custom Pack Reliability
General Hospital · 87d
Cleared Apr 12, 1996
CPR ORTHO HAND PACK
K960210 · FRG
Custom Pack Reliability
General Hospital · 87d
Cleared Apr 12, 1996
CPR TOTAL KNEE PACK
K960211 · FRG
Custom Pack Reliability
General Hospital · 87d
Cleared Apr 12, 1996
CPR TOTAL HIP PACK
K960213 · FRG
Custom Pack Reliability
General Hospital · 87d
Cleared Apr 12, 1996
GENERAL PROCEDURE KIT
K960248 · FMF
Physician Industries, Inc.
General Hospital · 87d
Cleared Apr 12, 1996
BRAUN HEMOSTASIS INTRODUCERS
K960406 · DYB
B.Braun Medical, Inc.
Cardiovascular · 74d
Cleared Apr 11, 1996
FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS
K950294 · LPL
Flexlens, Inc.
Ophthalmic · 442d
Cleared Apr 11, 1996
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC...
K951343 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 384d
Cleared Apr 11, 1996
LMI ARTERIAL EMBOLECTOMY CATHETER
K954760 · DXE
Lucas Medical, Inc.
Cardiovascular · 177d
Cleared Apr 11, 1996
PENEVAC SI.
K955166 · GEI
I.C Medical, Inc.
General & Plastic Surgery · 150d
Cleared Apr 11, 1996
FERTICARE PERSONAL THERAPEUTIC VIBRATOR
K955589 · KXQ
Multicept, Aps.
Obstetrics & Gynecology · 126d