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
111385–111408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 1993
PROMOTIONAL SUNGALSSES
K932416 · HQY
Associated Premium Corp.
Ophthalmic · 168d
Cleared Nov 02, 1993
DOCTOR DOWN --RESCUE WRAP
K932539 · KME
Three Dog Down
General Hospital · 160d
Cleared Nov 02, 1993
AGGRO/LINK CONTROL SOFTWARE
K932566 · JBX
Chrono-Log Corp.
Hematology · 159d
Cleared Nov 02, 1993
WIRE REINFORCED ENDOTRACHEAL TUBE
K932647 · BTR
Vitaid, Ltd.
Anesthesiology · 153d
Cleared Nov 02, 1993
FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2
K932657 · DAP
More Diagnostics
Hematology · 153d
Cleared Nov 02, 1993
EXTERNAL STABILITY PAD
K932979 · GCJ
Louisville Laboratories, Inc.
General & Plastic Surgery · 138d
Cleared Nov 02, 1993
VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500
K933181 · GFI
Valleylab, Inc.
General & Plastic Surgery · 125d
Cleared Nov 02, 1993
MODEL #510GE1500 LIVER ARRAY COIL
K933297 · LNH
Medic, Inc.
Radiology · 118d
Cleared Nov 02, 1993
KENDALL URODYNAMIC CATHETERS
K933399 · FEN
Kendall Healthcare Products Co....
Gastroenterology & Urology · 113d
Cleared Nov 02, 1993
ENDOSCOPIC INSTRUMENTS AND ACCESSDORIES
K933421 · GCJ
L.A.S.E.R., Inc.
General & Plastic Surgery · 112d
Cleared Nov 02, 1993
COMED TROGARD(TM) BLUNT TIP TROCAR/SLEEVE
K933456 · GCJ
Conmedcorp
General & Plastic Surgery · 111d
Cleared Nov 02, 1993
SORIN MONOLYTH VENOUS RESERVOIR
K933481 · DTN
Sorin Biomedical, Inc.
Cardiovascular · 125d
Cleared Nov 02, 1993
V-SIL
K933546 · ESD
Esschem, Inc.
Ear, Nose, Throat · 103d
Cleared Nov 02, 1993
EH-270 CORNEAL TOPOGRAPHER
K933556 · HLQ
Visioptic, Inc.
Ophthalmic · 104d
Cleared Nov 02, 1993
OLYMPUS MEASURING DEVICES
K933717 · FDS
Olympus Corp.
Gastroenterology & Urology · 95d
Cleared Nov 02, 1993
TRACTION PRODUCTIONS SPECTACLE FRAMES
K934249 · HQZ
Traction Productions, USA
Ophthalmic · 67d
Cleared Nov 02, 1993
ANIMAL NONPRESCRIPTION SUNGLASSES
K934304 · HQY
U.S. Toy Co., Inc.
Ophthalmic · 81d
Cleared Nov 02, 1993
AVIATOR NONPRESCRIPTION SUNGLASSES
K934305 · HQY
U.S. Toy Co., Inc.
Ophthalmic · 81d
Cleared Nov 02, 1993
BUTTERFLY NONPRESCRIPTION SUNGLASSES
K934307 · HQY
U.S. Toy Co., Inc.
Ophthalmic · 81d
Cleared Nov 02, 1993
CHILD NONPRESCRIPTION SUNGLASSES
K934308 · HQY
U.S. Toy Co., Inc.
Ophthalmic · 81d
Cleared Nov 02, 1993
DISCO SUNGLASSES NONPRESCRIPTION SUNGLASSES
K934309 · HQY
U.S. Toy Co., Inc.
Ophthalmic · 81d
Cleared Nov 01, 1993
CARDIO PERFECT, CARDIO PERFECT MD
K922898 · LOS
Cardio Control BV
Cardiovascular · 503d
Cleared Nov 01, 1993
SUR FLO THERMAL THERAPY PADS
K930634 · ILO
Buckman Co., Inc.
Physical Medicine · 266d
Cleared Nov 01, 1993
MULTITRAK-PLUS
K930894 · DSH
Zymed Medical Instrumentation
Cardiovascular · 252d