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
120577–120600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1991
SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION
K911105 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 148d
Cleared Aug 07, 1991
MMG BILE BAG
K911129 · EXF
Medical Technologies of Georgia
Gastroenterology & Urology · 146d
Cleared Aug 07, 1991
OVAL CUP BIOPSY FORCEP
K911155 · FCF
Endovations
Gastroenterology & Urology · 145d
Cleared Aug 07, 1991
CUFFABLE
K911213 · DXQ
Biomedical Dynamics, Inc.
Cardiovascular · 141d
Cleared Aug 07, 1991
IDEIA(TM) CHLAMYDIA, MODIFICATION
K911430 · LIC
Novo Nordisk Diagnostics, Ltd.
Microbiology · 132d
Cleared Aug 07, 1991
HEMOSPAL KIT B22
K911603 · KDI
C.G.H. Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Aug 07, 1991
MITRASHEER TRANSPLANT DRESSING
K911649 · MGP
Polymint Industrial Co. , Ltd.
General & Plastic Surgery · 117d
Cleared Aug 07, 1991
FMA TRANSLATOR
K912086 · BXB
Normandie Group, Inc.
Physical Medicine · 86d
Cleared Aug 07, 1991
DIGITAL SPHYGMOMANOMETER MODEL UA-833
K912118 · DXN
A&D Engineering, Inc.
Cardiovascular · 85d
Cleared Aug 07, 1991
DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 212
K912119 · DXN
A&D Engineering, Inc.
Cardiovascular · 85d
Cleared Aug 07, 1991
URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
K912120 · FBN
Olympus Corp.
Gastroenterology & Urology · 85d
Cleared Aug 07, 1991
DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE
K912129 · KNS
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 85d
Cleared Aug 07, 1991
OPERAND LUBRICATING JELLY
K912132 · FHX
General Medical Co.
Gastroenterology & Urology · 85d
Cleared Aug 07, 1991
MONARK ERGOMETERS
K912227 · ISD
Quinton, Inc.
Physical Medicine · 83d
Cleared Aug 07, 1991
LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING
K912253 · HQE
Ocular Instruments, Inc.
Ophthalmic · 78d
Cleared Aug 07, 1991
LANDERS NOTCHED VITRECTOMY LENS RING
K912268 · HNH
Ocular Instruments, Inc.
Ophthalmic · 77d
Cleared Aug 07, 1991
LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING
K912269 · HNH
Ocular Instruments, Inc.
Ophthalmic · 77d
Cleared Aug 07, 1991
TUBE HOUSING ASSEMBLIES
K912338 · ITY
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 75d
Cleared Aug 07, 1991
PHILIPS DIAGNOST 96
K912470 · JAA
Philips Medical Systems, Inc.
Radiology · 64d
Cleared Aug 07, 1991
GROUP A STREP POSITIVE AND NEGATIVE CONTROLS
K912868 · GTZ
Quidel Corp.
Microbiology · 40d
Cleared Aug 07, 1991
LATEX EXAMINATION GLOVES
K913033 · LYY
Reagent Hospital Prod. , Ltd.
General Hospital · 29d
Cleared Aug 05, 1991
GUARANTY HAIR REMOVAL SYSTEM
K905125 · KCX
Stephens Mfg. Co.
General & Plastic Surgery · 264d
Cleared Aug 02, 1991
SMART-EP
K904926 · GWJ
Intelligent Hearing Systems
Neurology · 275d
Cleared Aug 02, 1991
CATHLAB SILICONE BILIARY BALLOON CATHETER
K910917 · GCA
Cathlab Corp.
Gastroenterology & Urology · 150d