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
119521–119544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 1991
ICAN K DISSECTOR SPONGES
K914083 · GDY
Icn Pharmaceuticals, Inc.
General & Plastic Surgery · 28d
Cleared Oct 09, 1991
ICAN CYLINDRICAL SPONGES
K914086 · GDX
Icn Pharmaceuticals, Inc.
General & Plastic Surgery · 28d
Cleared Oct 09, 1991
LAPAROSCOPIC BALLOON RETRACTOR
K914203 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 20d
Cleared Oct 08, 1991
CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM
K902401 · FMF
Burron Medical, Inc.
General Hospital · 496d
Cleared Oct 08, 1991
ORTHODONTIC WIRE
K911231 · EJF
Masel Industries, Inc.
Dental · 202d
Cleared Oct 08, 1991
BIRD SENTRY AIR/OXYGEN MICROBLENDER
K911962 · BZR
Bird Products Corp.
Anesthesiology · 159d
Cleared Oct 08, 1991
ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM
K912019 · CAC
Gish Biomedical, Inc.
Anesthesiology · 154d
Cleared Oct 08, 1991
MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE
K912111 · FMF
Gerard Medical Enterprises, Inc.
General Hospital · 148d
Cleared Oct 08, 1991
I.V. STARR KIT
K912161 · LKB
Medical Device Inspection Co., Inc.
General Hospital · 145d
Cleared Oct 08, 1991
MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV
K912737 · LYU
Medical Armor Corp.
General Hospital · 109d
Cleared Oct 08, 1991
A-DEC KNEEBREAK 1030 CHAIR
K913059 · KLC
A-Dec, Inc.
Dental · 90d
Cleared Oct 08, 1991
LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK
K913109 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 88d
Cleared Oct 08, 1991
COHERENT NOVUS 3000 ARGON PHOTOCOAGULATOR
K913127 · GEX
Coherent Medical Group
General & Plastic Surgery · 85d
Cleared Oct 08, 1991
ACS VSW GUIDE WIRE
K913178 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Oct 08, 1991
NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL
K913259 · GKZ
Nova Biomedical Corp.
Hematology · 77d
Cleared Oct 08, 1991
MEGA PARACENTESIS KIT
K913382 · KKX
Mega Medical, Inc.
General Hospital · 71d
Cleared Oct 08, 1991
STACLOT(R) PROTEIN S TEST KIT
K913424 · GGP
American Bioproducts Co.
Hematology · 68d
Cleared Oct 08, 1991
WOUND CARE TRAY B
K913479 · MCY
Catalina Biomedical Corp.
General & Plastic Surgery · 63d
Cleared Oct 08, 1991
MARLOW VERRES NEEDLES
K913586 · GCT
Marlo Surgical Technology
Gastroenterology & Urology · 57d
Cleared Oct 08, 1991
FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM
K913721 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 49d
Cleared Oct 08, 1991
STERILE CHEST TUBE
K913733 · GBW
Vascular Products, Inc.
General & Plastic Surgery · 49d
Cleared Oct 08, 1991
2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH
K913841 · FGE
Endovations
Gastroenterology & Urology · 43d
Cleared Oct 08, 1991
PROGUARDII(TM) BLOOD COLLECTION DEVICE
K913914 · FMI
Care Medical Devices, Inc.
General Hospital · 35d
Cleared Oct 07, 1991
ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONADE DEVICE
K900623 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 606d