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
115273–115296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1992
BIO-OSS BLOCKS
K920508 · LYC
Geistlich-Pharma
Dental · 293d
Cleared Nov 24, 1992
S-ROM TOTAL HIP REPLACEMENT SYSTEM
K920739 · JDI
Joint Medical Products Corp.
Orthopedic · 279d
Cleared Nov 24, 1992
LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE
K921408 · EJK
Ultradent Products, Inc.
Dental · 245d
Cleared Nov 24, 1992
INFRARED LAMP
K922900 · ILY
Harrier, Inc.
Physical Medicine · 161d
Cleared Nov 24, 1992
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
K922905 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 161d
Cleared Nov 24, 1992
NEUROSIGN MODEL 100
K923056 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 153d
Cleared Nov 24, 1992
SAPPHIRE PREMIERE
K923303 · GWF
Medelec , Ltd.
Neurology · 141d
Cleared Nov 24, 1992
PLANMED CYTOGUIDE
K923471 · IZH
Planmed OY
Radiology · 133d
Cleared Nov 24, 1992
STERILE FILM WOUND DRESSING
K924008 · MGP
Innovative Technology , Ltd.
General & Plastic Surgery · 106d
Cleared Nov 24, 1992
CYTOLOGY BRUSH
K924104 · FDX
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 103d
Cleared Nov 24, 1992
SNARE FLEXIBLE
K924105 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 103d
Cleared Nov 24, 1992
BIOPSY FORCEPS
K924106 · KNW
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 103d
Cleared Nov 24, 1992
ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS
K924115 · JDI
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 102d
Cleared Nov 24, 1992
POLY-DIAL INSERTS
K924492 · LPH
Joint Medical Products Corp.
Orthopedic · 82d
Cleared Nov 24, 1992
DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4
K924593 · IXL
Philips Medical Systems, Inc.
Radiology · 75d
Cleared Nov 24, 1992
TRUE/ FLEX FIBULA RODS
K924656 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 70d
Cleared Nov 24, 1992
TRUE/FLEX METATARSAL RODS
K924657 · KTW
Applied Osteo Systems, Inc.
Orthopedic · 70d
Cleared Nov 24, 1992
THE DENTIST'S TOOTH POLISHER
K924739 · JEQ
Ranir/Dcp Corp.
Dental · 63d
Cleared Nov 24, 1992
P54-0 BEHIND THE EAR HEARING AID
K924887 · ESD
Electone, Inc.
Ear, Nose, Throat · 57d
Cleared Nov 24, 1992
P54 HEARING AID
K924888 · ESD
Electone, Inc.
Ear, Nose, Throat · 57d
Cleared Nov 24, 1992
RLN NERVE LOCATOR/MONITOR
K925008 · ETN
Rln Systems, Inc.
Ear, Nose, Throat · 53d
Cleared Nov 23, 1992
AUTO SASH (TM)
K904663 · FPA
Block Medical, Inc.
General Hospital · 773d
Cleared Nov 23, 1992
CEDETA
K915717 · LWM
D-W Intl.
Dental · 340d
Cleared Nov 23, 1992
QUICKTEST SYSTEM
K920015 · LHI
Q.I. Medical, Inc.
General Hospital · 326d