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
110377–110400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1994
BURRS
K934583 · GFF
American Medical Specialties, Inc.
General & Plastic Surgery · 125d
Cleared Jan 26, 1994
BISCO DUO LINK D/C LUTING COMPOSITE
K934596 · KLE
Bisco, Inc.
Dental · 124d
Cleared Jan 26, 1994
METHADONE ENZYME IMMUNOASSAY
K934667 · DJR
Diagnostic Reagents, Inc.
Toxicology · 119d
Cleared Jan 26, 1994
MEDICOOL PROTECTALL
K934703 · LDQ
Avc Regulatory Compliance/Technical...
General & Plastic Surgery · 118d
Cleared Jan 26, 1994
VB-1830/VB-1530, VIDEO BRONCHOSCOPE
K934920 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 103d
Cleared Jan 26, 1994
BII-PLAST
K934947 · LYC
Bio-Interfaces, Inc.
Dental · 100d
Cleared Jan 26, 1994
3M TEMPORARY CROWN & BRIDGE MATERIAL
K935041 · EBG
3M Company
Dental · 97d
Cleared Jan 26, 1994
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION
K935082 · LWM
3M Company
Dental · 96d
Cleared Jan 26, 1994
3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS
K935085 · LWM
3M Company
Dental · 96d
Cleared Jan 26, 1994
KOOLINER II
K935261 · EBI
GC America, Inc.
Dental · 84d
Cleared Jan 26, 1994
COOL LIGHT 300
K935423 · GCT
Endosurgical Development Corp.
Gastroenterology & Urology · 78d
Cleared Jan 26, 1994
PREPERITONEAL DISTENTION BALLOON SYSTEM
K935426 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 77d
Cleared Jan 26, 1994
SPONGER CABLE SYSTEM, MODIFICATION
K935481 · JDQ
Pioneer Surgical Technology
Orthopedic · 125d
Cleared Jan 26, 1994
ARGEDENT 77PF
K935507 · EJT
Argen Precious Metals, Inc.
Dental · 72d
Cleared Jan 26, 1994
ARGEDENT 78PF
K935508 · EJT
Argen Precious Metals, Inc.
Dental · 72d
Cleared Jan 26, 1994
RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE
K935522 · JES
Ranir/Dcp Corp.
Dental · 71d
Cleared Jan 26, 1994
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
K935561 · JEQ
Bausch & Lomb, Inc.
Dental · 70d
Cleared Jan 26, 1994
SURGICAL ACCESSORIES COCR CABLE SYSTEM
K935592 · JDQ
Surgical Accessories, Inc.
Orthopedic · 68d
Cleared Jan 26, 1994
JEDENTAL VLC DENTAL CURING LIGHT
K935718 · EAY
Jedental Co., Inc.
Dental · 57d
Cleared Jan 26, 1994
CHARISMA SUPERLIGHT
K935736 · EBF
Heraeus Kulzer, Inc.
Dental · 56d
Cleared Jan 26, 1994
PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT
K935791 · ESD
Phonak, Inc.
Ear, Nose, Throat · 50d
Cleared Jan 26, 1994
ARGELOY PARTIAL (NON-PRECIOUS)
K935829 · EJH
Argen Precious Metals, Inc.
Dental · 50d
Cleared Jan 26, 1994
VISION PROPHY PASTE WITH FLUORIDE
K935925 · EJR
Block Drug Company, Inc.
Dental · 44d
Cleared Jan 26, 1994
ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION)
K935972 · EJH
Argen Precious Metals, Inc.
Dental · 44d