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
119305–119328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1991
DUET BICYCLE/WHEELCHAIR
K913759 · IOR
Robert Hoening Mobility Systems, Inc.
Physical Medicine · 63d
Cleared Oct 24, 1991
510 DL POWERED WHEELCHAIRS
K913989 · INI
Am Scooters
Physical Medicine · 49d
Cleared Oct 24, 1991
MULTI-REACH II WAND MASSAGER
K914344 · IRO
Conair Corp.
Physical Medicine · 27d
Cleared Oct 24, 1991
POLAR PADS
K914434 · ILO
Breg, Inc.
Physical Medicine · 20d
Cleared Oct 23, 1991
SPOON FORCEPS, 11MM
K911364 · LQC
Northgate Technologies, Inc.
Gastroenterology & Urology · 209d
Cleared Oct 23, 1991
DRUG NEBULIZERS
K911422 · CAF
Intersurgical, Inc.
Anesthesiology · 260d
Cleared Oct 23, 1991
INVENTOR RT/EXPLORER TRAUMA UNIT
K911563 · IYB
Continental X-Ray Corp.
Radiology · 198d
Cleared Oct 23, 1991
HEPARIN COATED THERMODILUTION CATH & ACCESSORIES
K911710 · DQO
Sunscope Intl., Inc.
Cardiovascular · 189d
Cleared Oct 23, 1991
PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION
K911726 · KHL
Bausch & Lomb, Inc.
Ear, Nose, Throat · 195d
Cleared Oct 23, 1991
SWEMAC REISON BIPLANAR 300
K911739 · OXO
Seemac Reison AB Co.
Radiology · 189d
Cleared Oct 23, 1991
METERED DOSE INHALER (MDI) SPACER
K911807 · CAF
Health Products, Inc.
Anesthesiology · 183d
Cleared Oct 23, 1991
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED
K912065 · CAI
Intertech Resources, Inc.
Anesthesiology · 180d
Cleared Oct 23, 1991
SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY
K912079 · DTZ
3M Health Care, Sarns
Cardiovascular · 166d
Cleared Oct 23, 1991
CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY
K912158 · FOZ
Medical Device Inspection Co., Inc.
General Hospital · 160d
Cleared Oct 23, 1991
PROFESSIONAL INDIRECT OPHTHALMOSCOPE
K912397 · HLI
Clement Clarke, Inc.
Ophthalmic · 148d
Cleared Oct 23, 1991
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED
K912504 · CAI
Intertech Resources, Inc.
Anesthesiology · 140d
Cleared Oct 23, 1991
UNIPOLAR UPSIZING ADAPTOR
K912773 · DTD
Telectronics Pacing Systems, Inc.
Cardiovascular · 121d
Cleared Oct 23, 1991
EMS PERCUSSOR
K913014 · BYI
Engineered Medical Systems
Anesthesiology · 107d
Cleared Oct 23, 1991
MULTI-VIEW BIFOCALS
K913081 · HPX
Camp Contact Lenses
Ophthalmic · 107d
Cleared Oct 23, 1991
OCHSNER ULP BIFURCATION VASCULAR PROTHESIS
K913143 · DSY
Intervascular, Inc.
Cardiovascular · 99d
Cleared Oct 23, 1991
.010 HI-TORQUE PLUS(TM) GUIDE WIRE
K913328 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared Oct 23, 1991
CIBA CORNING MODEL 270 CO-OXIMETER
K913332 · DQA
Ciba Corning Diagnostics Corp.
Anesthesiology · 90d
Cleared Oct 23, 1991
I.V. PRIMING SET
K913333 · FPA
Gainor Medical Europe, Ltd.
General Hospital · 89d
Cleared Oct 23, 1991
STAMBI-CK
K913349 · JHW
Intl. Immunoassay Laboratories, Inc.
Chemistry · 89d