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
119017–119040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1991
MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES
K914460 · DRF
Medtronic Vascular
Cardiovascular · 46d
Cleared Nov 22, 1991
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
K914464 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 46d
Cleared Nov 22, 1991
DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY)
K914526 · GCJ
Davol, Inc.
General & Plastic Surgery · 44d
Cleared Nov 22, 1991
CEQUAL(TM)
K914527 · KPS
General Electric Co.
Radiology · 43d
Cleared Nov 22, 1991
LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM
K914547 · GCJ
Baxter Healthcare Corp
General & Plastic Surgery · 42d
Cleared Nov 22, 1991
DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED
K914602 · KRH
The Heart Valve Div. Medtronic...
Cardiovascular · 38d
Cleared Nov 22, 1991
CVM
K914619 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 37d
Cleared Nov 22, 1991
MICROAIR 3500
K914674 · IOQ
Gsi Development Co.
Physical Medicine · 35d
Cleared Nov 22, 1991
ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR
K914750 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Nov 22, 1991
WHEELCHARIOT LIGHTWEIGHT MANUAL WHEELCHAIR
K914785 · IOR
Wheelchariots, Inc.
Physical Medicine · 30d
Cleared Nov 22, 1991
IMMULITE DIGOXIN
K914833 · DPO
Cirrus Diagnostics, Inc.
Toxicology · 28d
Cleared Nov 22, 1991
OTOSONIC ACS-ASP
K914939 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 18d
Cleared Nov 22, 1991
BELTONE CLEARVOICE
K914940 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 18d
Cleared Nov 22, 1991
SHARP ENDOKNOT PUSHER
K914967 · GCJ
Sharpe Endosurgical Corp.
General & Plastic Surgery · 17d
Cleared Nov 21, 1991
SNAP-LOCK MICRO PORT, MODIFICATION
K910448 · LJT
Infusaid Corp.
General Hospital · 303d
Cleared Nov 21, 1991
HYSTEROFLATOR 1500
K911844 · HIG
F.M. Wiest USA, Inc.
Obstetrics & Gynecology · 210d
Cleared Nov 21, 1991
EXTERNAL GASTROSTOMY TUBE RETAINER
K912575 · FPD
Sandoz Nutrition
Gastroenterology & Urology · 162d
Cleared Nov 21, 1991
CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP
K914015 · GBZ
Pilling Co.
General & Plastic Surgery · 73d
Cleared Nov 21, 1991
ACE OPEN-BACK HALO RING
K914858 · JEC
Ace Medical Co.
Orthopedic · 23d
Cleared Nov 20, 1991
DTF-1000LL,DTF-1000
K911118 · EIB
Cp Medical
Dental · 253d
Cleared Nov 20, 1991
HEART NEBULIZER FLOWMETER ADAPTOR
K913015 · CAF
B&B Medical Technologies, Inc.
Anesthesiology · 135d
Cleared Nov 20, 1991
KTP/532 AND KTP/YAG
K913758 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared Nov 20, 1991
INTERPRET(TM) CATHETER LINEAR TRANSLATOR
K913763 · LYK
Intertherapy, Inc.
Cardiovascular · 90d
Cleared Nov 20, 1991
SIMPEX INC. SURGICAL DRESSING
K913794 · GDY
Simpex, Inc.
General & Plastic Surgery · 89d