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
96505–96528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1996
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
K962519 · LCD
Behring Diagnostics, Inc.
Toxicology · 69d
Cleared Sep 04, 1996
KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS
K962595 · FFS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 64d
Cleared Sep 04, 1996
GYREX V-EP
K962618 · LNH
Elscint, Inc.
Radiology · 63d
Cleared Sep 03, 1996
SELF PROPELLED ROBOTIC WHEEL (SPRW)
K950025 · ITI
Datatran, Inc.
Physical Medicine · 608d
Cleared Sep 03, 1996
LFS LIPOGEL ASSAY KIT
K960785 · JHO
Zaxis, Inc.
Chemistry · 190d
Cleared Sep 03, 1996
DURASIL (MODIFICATION)
K961410 · MDA
The S. F. Group, Inc.
General & Plastic Surgery · 175d
Cleared Sep 03, 1996
SUNRISE CURING LAMP
K962192 · EBF
Sunrise Technologies, Inc.
Dental · 88d
Cleared Sep 03, 1996
SURESCAN
K962242 · GEX
Clinicon Corp.
General & Plastic Surgery · 84d
Cleared Sep 03, 1996
SELECT SHOULDER COCR HUMERAL STEM COMPONENT
K962315 · KWT
Intermedics Orthopedics
Orthopedic · 78d
Cleared Sep 03, 1996
3D-SPINE
K962377 · KQX
Skill Technologies, Inc.
Neurology · 75d
Cleared Sep 03, 1996
PULPDENT RESILUTE II
K962383 · EMA
Pulpdent Corp.
Dental · 75d
Cleared Sep 03, 1996
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K962401 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 74d
Cleared Sep 03, 1996
DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)
K962439 · MGQ
Richard Hamer Assoc., Inc.
General & Plastic Surgery · 71d
Cleared Sep 03, 1996
SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)
K962496 · FTL
Tissue Technologies, Inc.
General & Plastic Surgery · 69d
Cleared Sep 03, 1996
SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM
K962616 · HRS
Synthes (Usa)
Orthopedic · 62d
Cleared Sep 03, 1996
UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE
K962935 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 36d
Cleared Sep 03, 1996
ORTHO-ONE
K962946 · DYH
Bisco, Inc.
Dental · 36d
Cleared Sep 03, 1996
SIREMOBIL COMPACT
K963093 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 26d
Cleared Aug 30, 1996
VARELISA HELICOBACTER PYLORI ANTIBODIES
K953873 · LYR
Elias U.S.A., Inc.
Microbiology · 379d
Cleared Aug 30, 1996
RETICULOCYTE METHOD
K954607 · GKL
Bayer Corp.
Hematology · 331d
Cleared Aug 30, 1996
ROBISON & SMITH SURGICAL PACKS
K955586 · FYA
Robison & Smith, Inc.
General Hospital · 267d
Cleared Aug 30, 1996
E. HISTOLYTICA TEST
K955895 · KHW
Techlab, Inc.
Microbiology · 248d
Cleared Aug 30, 1996
GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR
K960857 · JKA
Greiner America, Inc.
Chemistry · 182d
Cleared Aug 30, 1996
GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR
K960858 · JKA
Greiner America, Inc.
Chemistry · 182d