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
112633–112656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1993
DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS
K926224 · GEX
Diomedics, Inc.
General & Plastic Surgery · 224d
Cleared Jul 22, 1993
PEAK FLOW METER
K926307 · BZH
Monaghan Medical Corp.
Anesthesiology · 219d
Cleared Jul 22, 1993
ACCUFLEX DYNAMIC ELBOW ORTHOSIS
K926391 · IQI
Regulatory & Marketing Services, Inc.
Physical Medicine · 213d
Cleared Jul 22, 1993
LASER AND EMPHASIS SCLEROSTOMY TIP
K926470 · HQF
Summit Technology, Inc.
Ophthalmic · 206d
Cleared Jul 22, 1993
MEDNEXT 1000 BONE DISSECTING SYSTEM
K926547 · HSZ
Mednext, Inc.
Orthopedic · 203d
Cleared Jul 22, 1993
MARCO SURGISCOPE OPERATION MICROSCOPES
K930439 · HRM
Marco Ophthalmic, Inc.
General & Plastic Surgery · 177d
Cleared Jul 22, 1993
ENDOSCOPIC UMBRELLA RETRACTOR
K930462 · GCJ
Surgical Technologies, Inc.
General & Plastic Surgery · 175d
Cleared Jul 22, 1993
ADAIR/VERESS NEEDLE INTRODUCER SET
K930568 · GCB
Medical Dynamics, Inc.
General & Plastic Surgery · 177d
Cleared Jul 22, 1993
ACCUTRAC TRACTION UNIT
K930691 · ITH
I-Rep, Inc.
Physical Medicine · 162d
Cleared Jul 22, 1993
THE MODEL 3003 SCALER
K930698 · ELC
Dentsply Intl.
Dental · 162d
Cleared Jul 22, 1993
DORMIE NECK SUPPORT SYSTEM
K930730 · IQK
The Western Diagnostics Co.
Physical Medicine · 161d
Cleared Jul 22, 1993
COOK ASPIRATION UNIT
K930900 · JCX
Cook Ob/Gyn
General & Plastic Surgery · 150d
Cleared Jul 22, 1993
IQ TUPTAKE ASSAY
K931294 · KHQ
Becton Dickinson Advanced Diagnostics
Chemistry · 129d
Cleared Jul 22, 1993
VARIOLINK
K931309 · EBF
Ivoclar North America, Inc.
Dental · 129d
Cleared Jul 22, 1993
TMR-670
K931349 · INO
Pride Health Care, Inc.
Physical Medicine · 127d
Cleared Jul 22, 1993
GLENROE CHAIN
K931462 · ECI
Glenroe Technologies, Inc.
Dental · 120d
Cleared Jul 22, 1993
VIVAGLASS LINER
K931502 · EJK
Ivoclar North America, Inc.
Dental · 119d
Cleared Jul 22, 1993
ENDOSCOPIC INSTRUMENT HOLDER
K931705 · GCJ
Mayaguez Medical Center
General & Plastic Surgery · 107d
Cleared Jul 22, 1993
ZERO GRAVITY WHEELCHAIR
K931751 · IOR
General Components Intl., Inc.
Physical Medicine · 105d
Cleared Jul 22, 1993
UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER
K931774 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 104d
Cleared Jul 22, 1993
SYMBIOSIS ENT SURGICAL INSTRUMENTS
K931793 · LRC
Symbiosis Corp.
Ear, Nose, Throat · 101d
Cleared Jul 22, 1993
NEEDLESAFE HANDGUARD
K931813 · FPA
Adrian Anesthesia Systems, Inc.
General Hospital · 105d
Cleared Jul 22, 1993
SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT
K931857 · EBC
Confi-Dental Products Co.
Dental · 100d
Cleared Jul 22, 1993
PRIMADRY PRODUCT LINE
K931868 · EBC
Ultradent Products, Inc.
Dental · 99d