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
102769–102792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 1995
DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC
K951064 · FTY
S-E Sales & Distribution, Inc.
General & Plastic Surgery · 72d
Cleared May 19, 1995
STERRAD STERILIZATION POUCH
K951295 · KCT
Advanced Sterilization Products
General Hospital · 58d
Cleared May 19, 1995
STRATO/INFUSAIND MICROPORT VASCULAR ACC. SYSTEM
K951873 · LJT
Strato/Infusaid, Inc.
General Hospital · 28d
Cleared May 19, 1995
STRATO/INFUSAID MACROPORT VASCULAR ACC. SYSTEM
K951874 · LJT
Strato/Infusaid, Inc.
General Hospital · 28d
Cleared May 19, 1995
PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K952009 · CAI
Prima, Inc.
Anesthesiology · 21d
Cleared May 18, 1995
AT42
K930576 · HCC
Autoject Systems, Inc.
Neurology · 833d
Cleared May 18, 1995
AT64 SCR
K930577 · HCC
Autoject Systems, Inc.
Neurology · 833d
Cleared May 18, 1995
LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)
K942858 · HIS
Suretex, Ltd.
Obstetrics & Gynecology · 428d
Cleared May 18, 1995
75K STAIGHT DRILL
K943541 · HBE
Stryker Corp.
Neurology · 300d
Cleared May 18, 1995
ALTRA FLUX(TM) 140 HEMODIALYZER
K945620 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 184d
Cleared May 18, 1995
MCA(TM) 130 HEMODIALYZER
K945623 · FJI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 184d
Cleared May 18, 1995
MCA(TM) 160 HEMODIALYZER
K945624 · FJI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 184d
Cleared May 18, 1995
155 SCE(TM) HEMODIALYZER
K945631 · FJI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 183d
Cleared May 18, 1995
MEDICAL SUPPORT STOCKINGS
K951234 · DWL
Jobst A Beiersdorf Co.
General Hospital · 59d
Cleared May 18, 1995
AXSYM BARBITURATES II U
K951253 · DIS
Abbott Laboratories
Toxicology · 58d
Cleared May 18, 1995
AXSYM OPIATES
K951287 · DJG
Abbott Laboratories
Toxicology · 58d
Cleared May 18, 1995
RIB RESECTOR
K951492 · HAO
United States Surgical, A Division of...
Neurology · 48d
Cleared May 18, 1995
STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM
K951872 · LJT
Strato/Infusaid, Inc.
General Hospital · 27d
Cleared May 17, 1995
SPACELABS MEDICAL ECG MODULE (MODEL 90492)
K942058 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 383d
Cleared May 17, 1995
DI ISOLATION GOWN
K942351 · FYC
Derekduck Industries Corp.
General Hospital · 365d
Cleared May 17, 1995
COMFIT (PINK)
K943601 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 296d
Cleared May 17, 1995
ALL POLYETHYLENE CEMENTED ACETABULAR CUP
K943696 · JDI
Depuy, Inc.
Orthopedic · 292d
Cleared May 17, 1995
ECLIPSE 4 ELECTROCARDIOGRAPH
K943959 · LOS
Burdick, Inc.
Cardiovascular · 275d
Cleared May 17, 1995
PRECISION OSTEOLOCK FEMORAL COMPONENT
K944592 · LPH
Howmedica Corp.
Orthopedic · 240d