FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83593–83616 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 2000
LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE
K994255 · LYY
Pt. Maja Agung Latexindo
General Hospital · 52d
Cleared Feb 07, 2000
RESIN TOOTH BONDING AGENT
K994302 · KLE
Parkell, Inc.
Dental · 48d
Cleared Feb 07, 2000
ARABESK FLOW
K994304 · EBF
Voco GmbH
Dental · 48d
Cleared Feb 06, 2000
EXCELART WITH PIANISSIMO
K993803 · LNH
Toshiba America Mri, Inc.
Radiology · 89d
Cleared Feb 04, 2000
BARCOMED 2MP2
K000015 · LLZ
Barco N.V.
Radiology · 32d
Cleared Feb 04, 2000
ENTEC REFLEX WAND 55, MODEL E4055-00
K000036 · GEI
Arthrocare Corp.
General & Plastic Surgery · 29d
Cleared Feb 04, 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA...
K000074 · GEI
Arthrocare Corp.
General & Plastic Surgery · 24d
Cleared Feb 04, 2000
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
K000079 · HAM
Nikomed U.S.A., Inc.
General & Plastic Surgery · 24d
Cleared Feb 04, 2000
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
K000131 · LDJ
Phamatech
Toxicology · 17d
Cleared Feb 04, 2000
POROCOAT PRODIGY HIP PROSTHESIS
K000207 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 11d
Cleared Feb 04, 2000
VITALOGRAPH MICRO
K991412 · BZH
Vitalograph, Inc.
Anesthesiology · 287d
Cleared Feb 04, 2000
ILM ENDOTRACHEAL TUBE
K991580 · BTR
The Laryngeal Mask Co., Ltd.
Anesthesiology · 273d
Cleared Feb 04, 2000
WILTSE SYSTEM
K992012 · KWQ
Advanced Spine Fixation Systems, Inc.
Orthopedic · 234d
Cleared Feb 04, 2000
ACUMED MODULAR SHOULDER SYSTEM
K992525 · HSD
Acu Med, Inc.
Orthopedic · 191d
Cleared Feb 04, 2000
ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)
K992805 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 168d
Cleared Feb 04, 2000
I.CO.S SCREW
K993762 · HWC
New Deal, S.A.
Orthopedic · 88d
Cleared Feb 04, 2000
ULTRACLIP TISSUE MARKER
K993785 · GDW
Inrad
General & Plastic Surgery · 88d
Cleared Feb 04, 2000
SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C
K993834 · GEX
Cardiofocus, Inc.
General & Plastic Surgery · 84d
Cleared Feb 04, 2000
KAC-63 KNEE ARRAY COIL
K993898 · MOS
Mri Devices Corp.
Radiology · 80d
Cleared Feb 04, 2000
ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH...
K993943 · MEH
Encore Orthopedics, Inc.
Orthopedic · 77d
Cleared Feb 04, 2000
POLYPROPYLENE
K993997 · GAW
Trading Consultants and Distributors...
General & Plastic Surgery · 72d
Cleared Feb 04, 2000
NYLON
K993998 · GAR
Trading Consultants and Distributors...
General & Plastic Surgery · 72d
Cleared Feb 04, 2000
SILK
K993999 · GAP
Trading Consultants and Distributors...
General & Plastic Surgery · 72d
Cleared Feb 04, 2000
POLYESTER
K994000 · GAT
Trading Consultants and Distributors...
General & Plastic Surgery · 72d