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
109441–109464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1994
ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW
K932862 · HWC
Smith and Nephew Donjoy, Inc.
Orthopedic · 272d
Cleared Mar 10, 1994
STERILE WATER
K933526 · JOL
Trinity Laboratories, Inc.
General Hospital · 232d
Cleared Mar 10, 1994
ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM
K934044 · HWC
Smith and Nephew Donjoy, Inc.
Orthopedic · 203d
Cleared Mar 10, 1994
PROFORM HIP SYSTEM
K934161 · JDO
Stelkast Company
Orthopedic · 195d
Cleared Mar 10, 1994
SNAP STERNUM SAW
K935517 · HAB
Surgiquip, Inc.
General & Plastic Surgery · 112d
Cleared Mar 10, 1994
SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP
K935905 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Mar 10, 1994
MICROTRACK
K935929 · MCW
Devices For Vascular Intervention, Inc.
Cardiovascular · 87d
Cleared Mar 10, 1994
GC FUJI COAT LC
K935961 · KLE
GC America, Inc.
Dental · 87d
Cleared Mar 10, 1994
LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)
K936048 · FST
Cogent Light Technologies, Inc.
General & Plastic Surgery · 80d
Cleared Mar 10, 1994
AESCULAP SKIN GRAFT MESHER
K936186 · FZW
Aesculap, Inc.
General & Plastic Surgery · 77d
Cleared Mar 10, 1994
CATHETER INSERTION TRAY
K936261 · FMI
Medcare Custom Packaging, Inc.
General Hospital · 80d
Cleared Mar 10, 1994
STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER
K940130 · FPP
Stryker Corp.
General Hospital · 66d
Cleared Mar 10, 1994
NEW GEAR RELEASABLE HEADGEAR
K940410 · DZB
Ortho Kinetics Corp.
Dental · 42d
Cleared Mar 09, 1994
FLUID PUMP, CP #3
K914524 · FEB
United States Endoscopy Group, Inc.
General Hospital · 881d
Cleared Mar 09, 1994
GO-CLEAN
K922110 · FRR
Viva-Tek Assoc., Inc.
General Hospital · 673d
Cleared Mar 09, 1994
MEGABEAM RADIAL EMIT SHAPE FIBER OPTIC DELIV SYST
K924258 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 562d
Cleared Mar 09, 1994
LAPAROSCOPY SET
K924485 · HET
Owens Precision Systems, Inc.
Obstetrics & Gynecology · 552d
Cleared Mar 09, 1994
REPLICA(TM) TOTAL HIP SYSTEM
K926156 · LPH
Osteo Technology, Inc.
Orthopedic · 457d
Cleared Mar 09, 1994
SHARPLAN ND:YAG SURGICAL LASER, MODEL 3060 SHARPLASER 60
K926543 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 433d
Cleared Mar 09, 1994
LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE
K930756 · HET
Endo Technic Corp.
Obstetrics & Gynecology · 390d
Cleared Mar 09, 1994
HM-880 I
K932817 · GEI
Hill-Med, Inc.
General & Plastic Surgery · 273d
Cleared Mar 09, 1994
ERBOTOM ICC 350
K933002 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 261d
Cleared Mar 09, 1994
REAGENTS FOR HITACHI ISE
K933383 · JIX
Alko Diagnostic Corp.
Chemistry · 270d
Cleared Mar 09, 1994
OSTEONICS OMNIFIT FORGED HIP STEM SERIES
K933561 · JDI
Osteonics Corp.
Orthopedic · 230d