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
108649–108672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1994
MULTIPLE FRAGMENT PLATE
K931687 · HRS
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
SEMI-TUBULAR PLATE
K931688 · HRS
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
SMALL STRAIGHT PLATE
K931689 · HRS
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
STRAIGHT MINI-PLATE
K931691 · HRS
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
1/3 TUBULAR PLATE
K931693 · HRS
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
1/4 TUBULAR PLATE
K931694 · HRS
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
BIRTCHER ENDOSCOPIC CORKSCREW
K931771 · HET
Birtcher Medical Systems, Inc.
Obstetrics & Gynecology · 381d
Cleared Apr 25, 1994
CORTICAL BONE SCREW
K931790 · HWC
Onyx Medical Corp.
Orthopedic · 378d
Cleared Apr 25, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)
K932728 · KNK
Eastman Kodak Company
Chemistry · 322d
Cleared Apr 25, 1994
BIRTCHER LAPAROSCOPE AND ACCESSORIES
K932987 · GCJ
Birtcher Medical Systems, Inc.
General & Plastic Surgery · 311d
Cleared Apr 25, 1994
MICROPREP CAVITY PREPERATION SYSTEM
K932997 · KOJ
Sunrise Technologies, Inc.
Dental · 311d
Cleared Apr 25, 1994
KODAK EKTACHEM DTSC II SLIDES (LI)
K934106 · JIH
Eastman Kodak Company
Toxicology · 245d
Cleared Apr 25, 1994
ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS
K934126 · DZE
Implant Innovations, Inc.
Dental · 243d
Cleared Apr 25, 1994
ZIRCONIUM ALLOY UNI-POLAR HEAD
K934353 · KWL
Smith & Nephew Richards, Inc.
Orthopedic · 229d
Cleared Apr 25, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE
K934413 · CIT
Eastman Kodak Company
Chemistry · 227d
Cleared Apr 25, 1994
OTOVIEW ENDOSCOPY SYSTEM
K934432 · EWA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 224d
Cleared Apr 25, 1994
MRI RESONANCE DIAGNOSTIC DEVICE ACCESORY
K934538 · LNH
Noise Cancellation Technologies
Radiology · 217d
Cleared Apr 25, 1994
CANCELLOUS BONE SCREW
K934615 · HWC
Onyx Medical Corp.
Orthopedic · 210d
Cleared Apr 25, 1994
CANCELLOUS BONE SCREW
K934616 · HWC
Onyx Medical Corp.
Orthopedic · 210d
Cleared Apr 25, 1994
RIZA-RIBE NEEDLE
K935031 · HET
R-Med, Inc.
Obstetrics & Gynecology · 187d
Cleared Apr 25, 1994
INSULATED FORCEPS, BIOPSY FORCEPS, SCISSORS
K935071 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 182d
Cleared Apr 25, 1994
THE GRAFTOLOGER
K935753 · HWE
Neoligaments, Ltd.
Orthopedic · 150d
Cleared Apr 25, 1994
BIRTCHER PERICARDIAL KNIVES
K936114 · GCJ
Birtcher Medical Systems, Inc.
General & Plastic Surgery · 439d
Cleared Apr 25, 1994
ENLINE MONOPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS
K940157 · GCJ
Surgigus Instruments, Inc.
General & Plastic Surgery · 112d