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
83089–83112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 04, 2000
PLAIN/CHROMIC CATGUT
K994002 · GAL
Trading Consultants and Distributors...
General & Plastic Surgery · 72d
Cleared Feb 04, 2000
MALLORY/HEAD SMOOTH FEMORAL COMPONENT
K994007 · JDI
Biomet, Inc.
Orthopedic · 72d
Cleared Feb 04, 2000
KARL STORZ AUTOCLAVABLE CAMERA HEAD
K994090 · FET
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 63d
Cleared Feb 04, 2000
MR ENHANCER
K994117 · LNH
I.Z.I. Corp.
Radiology · 60d
Cleared Feb 04, 2000
COALESCENT SURGICAL SUTURED-CLIP
K994160 · FZP
Coalescent Surgical
General & Plastic Surgery · 57d
Cleared Feb 04, 2000
INTURIS SUITE
K994210 · LLZ
Philips Medical Systems, Inc.
Radiology · 52d
Cleared Feb 04, 2000
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
K994211 · KKX
Dentsply Intl.
General Hospital · 52d
Cleared Feb 04, 2000
DIMENSION TRNF FLEX REAGENT CARTRIDGE
K994294 · DDG
Dade Behring, Inc.
Immunology · 45d
Cleared Feb 04, 2000
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
K994315 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 44d