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
103825–103848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1995
SILCLEAR TUBING
K943992 · FPK
Degania Silicone , Ltd.
General Hospital · 212d
Cleared Mar 16, 1995
AIRSEP NEWLIFE AIR OUTLET OPTION
K944020 · CAF
Airsep Corp.
Anesthesiology · 212d
Cleared Mar 16, 1995
PARAGON PORTABLE
K945041 · FNM
Pegabus Egerton, Ltd.
General Hospital · 153d
Cleared Mar 16, 1995
ELITE 3 LOW AIR LOSS BED
K945042 · FNL
Pegabus Egerton, Ltd.
General Hospital · 153d
Cleared Mar 16, 1995
ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM
K945719 · CBT
Sherwood Medical Co.
Anesthesiology · 115d
Cleared Mar 16, 1995
CARDIOVIT AT-1, P-80
K946205 · DPS
Schiller America, Inc.
Cardiovascular · 85d
Cleared Mar 16, 1995
LAPAROSCOPE AND ACCESSORIES FOR OB/GYN
K950232 · HET
Olympus America, Inc.
Obstetrics & Gynecology · 66d
Cleared Mar 16, 1995
AUROLITE 55
K950858 · EJT
Argen Precious Metals, Inc.
Dental · 17d
Cleared Mar 16, 1995
KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE...
K951060 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 14d
Cleared Mar 16, 1995
NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM AND ACCESSORIES
K951086 · GCJ
American Hydro-Surgical Instruments,...
General & Plastic Surgery · 7d
Cleared Mar 15, 1995
INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04
K933278 · KRG
Intermedics, Inc.
Cardiovascular · 624d
Cleared Mar 15, 1995
3000 ELECTRONIC INSUFFLATOR MODIFICATION
K934115 · HIF
Cabot Medical Corp.
Obstetrics & Gynecology · 568d
Cleared Mar 15, 1995
DYNAPHOR(TM) TWO
K935868 · EGJ
Maxxim Medical
Physical Medicine · 464d
Cleared Mar 15, 1995
OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM
K942900 · MEH
Osteonics Corp.
Orthopedic · 268d
Cleared Mar 15, 1995
DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT
K943150 · MRR
Genzyme Corp.
Chemistry · 258d
Cleared Mar 15, 1995
CUTIPLAST STERIL
K943363 · MGP
Beiersdorf, Inc.
General & Plastic Surgery · 245d
Cleared Mar 15, 1995
BACK SPECIALIST
K944329 · INQ
Health Care Mfg., Inc.
Physical Medicine · 190d
Cleared Mar 15, 1995
OLYMPUS GLUCOSE REAGENT
K944406 · CFR
Olympus America, Inc.
Chemistry · 188d
Cleared Mar 15, 1995
ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
K944691 · GGN
International Technidyne Corp.
Hematology · 173d
Cleared Mar 15, 1995
MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)
K945809 · FMI
Sherwood Medical Co.
General Hospital · 107d
Cleared Mar 15, 1995
COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES
K946304 · GEX
Lumenis, Inc.
General & Plastic Surgery · 77d
Cleared Mar 15, 1995
SURGICAL STAPLE MARKER
K950006 · GDW
Biopsys Medical, Inc.
General & Plastic Surgery · 71d
Cleared Mar 15, 1995
SURGICAL INSTRUMENT GUIDE
K950007 · GDF
United States Surgical, A Division of...
General & Plastic Surgery · 71d
Cleared Mar 15, 1995
DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD
K950180 · DLI
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 57d