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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
153433–153456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1984
MOBILIZER
K840551 · ION
Lossing Orthopedic, Inc.
Physical Medicine · 44d
Cleared Mar 23, 1984
ELECTRODE PLACEMENT SLEEVE
K840591 · GXY
Bio-Stimu Trend Corp.
Neurology · 43d
Cleared Mar 23, 1984
ELECTRODE PLACEMENT LUMBAR SHORTS
K840592 · GXY
Bio-Stimu Trend Corp.
Neurology · 43d
Cleared Mar 23, 1984
QUINIDINE CALIBRATOR
K840597 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 43d
Cleared Mar 23, 1984
MASTERFOOT CAST HEEL
K840617 · LGF
Seton Products, Inc.
Orthopedic · 39d
Cleared Mar 23, 1984
FLO-GARD 4000 VOLUMETRIC INFUSION
K840644 · LDR
Travenol Laboratories, S.A.
General Hospital · 37d
Cleared Mar 23, 1984
CRP SLIDE TEST KIT
K840699 · DCN
Difco Laboratories, Inc.
Immunology · 36d
Cleared Mar 23, 1984
POLYP-SAVER SLEVE
K840800 · OCZ
Jayco Pharmaceuticals
Gastroenterology & Urology · 29d
Cleared Mar 23, 1984
DIFFERENTIATION DISKS SPS
K840804 · JTO
Difco Laboratories, Inc.
Microbiology · 28d
Cleared Mar 23, 1984
MICRODASE
K840819 · JTO
Remel Co.
Microbiology · 28d
Cleared Mar 23, 1984
TREONIC C30
K840823 · LDR
Vickers America Medical Corp.
General Hospital · 28d
Cleared Mar 23, 1984
OHIO 3000 INFANT WARMER SYSTEM
K840857 · FMT
Ohio Medical Products
General Hospital · 28d
Cleared Mar 23, 1984
OHIO 3300 INFANT WARMER SYSTEM
K840858 · FMT
Ohio Medical Products
General Hospital · 28d
Cleared Mar 23, 1984
STREP-A-CHEK TUBE
K840884 · JTO
E-Y Laboratories, Inc.
Microbiology · 25d
Cleared Mar 23, 1984
CLOSTRIDIUM DIFFICILE AGAR DEEP &
K840889 · JSI
Remel Co.
Microbiology · 25d
Cleared Mar 23, 1984
BUFFERED CYE AGAR DEEP W/SUPPLEMENTS
K840890 · JSJ
Remel Co.
Microbiology · 25d
Cleared Mar 23, 1984
PHOTO-THERAPY EYE PROTECTOR
K840894 · FOK
A & A Medical Supplies Co.
General Hospital · 25d
Cleared Mar 23, 1984
DIFFERENTIATION DISKS ALA
K840896 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Mar 23, 1984
SYRINGE, PISTON, ARTERIAL BLOOD SAMPL
K840924 · FMF
Medcare Disp Products, Inc.
General Hospital · 21d
Cleared Mar 23, 1984
OHIO HEAT REFLECTING PATCH
K840967 · FMI
Ohio Medical Products
General Hospital · 17d
Cleared Mar 23, 1984
PRESERV TRANSPORT & CULTURE PACK
K840968 · JTW
Preventive Diagnostics Corp.
Microbiology · 17d
Cleared Mar 23, 1984
NIACIN REAGENT STRIP
K840981 · MJD
Remel Co.
Microbiology · 17d
Cleared Mar 23, 1984
PRESERV CARY BLAIR TRANSPORT PACK
K840990 · JTW
Preventive Diagnostics Corp.
Microbiology · 16d
Cleared Mar 23, 1984
PRESERV BUFFERED GLYCEROL SALINE
K840991 · JTW
Preventive Diagnostics Corp.
Microbiology · 16d