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
142081–142104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 1986
ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K863710 · IZH
Ausonics Pty , Ltd.
Radiology · 21d
Cleared Oct 14, 1986
BANDAGE, GAUZE, TWO-PLY, VARIOUS SIZES
K863713 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 21d
Cleared Oct 14, 1986
BANDAGE, GAUZE, SIX-PLY, VARIOUS SIZES
K863714 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 21d
Cleared Oct 14, 1986
NORFOLK MEDICAL POSI-GRIP 'HUBER POINT' NEEDLE
K863721
Norfolk Medical Products, Inc.
General & Plastic Surgery · 21d
Cleared Oct 14, 1986
INSTRUMENT STERILIZATION TRAY
K863726 · FSM
Medical Technology Development Corp.
General & Plastic Surgery · 21d
Cleared Oct 14, 1986
TOWEL PACK, SURGICAL
K863733
East Texas Lighthouse For the Blind
General & Plastic Surgery · 21d
Cleared Oct 14, 1986
SPONGES STERILE TWIN PAKT AND SINGLES
K863737 · EFQ
Hermitage Hospital Products, Inc.
General & Plastic Surgery · 21d
Cleared Oct 14, 1986
PA EQUALIZER
K863787 · ESD
Electone, Inc.
Ear, Nose, Throat · 18d
Cleared Oct 14, 1986
SAWBLADE
K863788 · GFA
Tava Surgical Instruments
General & Plastic Surgery · 18d
Cleared Oct 14, 1986
JAW FIXATION ASSEMBLY
K863799 · DYX
Medical Products & Research, Inc.
Dental · 15d
Cleared Oct 14, 1986
ENDOSCOPIC VIDEO CAMERA
K863800 · KQM
Technology For Imaging, Inc.
General & Plastic Surgery · 15d
Cleared Oct 14, 1986
THE S. CORDERO STYLUS
K863808 · GDZ
S. Cordero Co.
General & Plastic Surgery · 14d
Cleared Oct 14, 1986
BAG SPIKE EXTENSION SET
K863814 · FPA
Med Fusion Systems, Inc.
General Hospital · 14d
Cleared Oct 14, 1986
VIVADENT FILPIN
K863831 · EBL
Vivadent (Usa), Inc.
Dental · 14d
Cleared Oct 14, 1986
POST TRAY
K863836 · EHY
Market Masters, Inc.
Dental · 14d
Cleared Oct 14, 1986
MANAN BREST TUMOR LOCALIZATION NEEDLE
K863848 · GAA
Manan Manufacturing Co., Inc.
General & Plastic Surgery · 14d
Cleared Oct 14, 1986
DRESSING, FIRST AID, FIELD, VARIOUS SIZES
K863850 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 12d
Cleared Oct 14, 1986
S-RAY CAMERA
K863856 · LMC
Uni-Quatro Industries
Radiology · 12d
Cleared Oct 14, 1986
MAMM-AIRE
K863890 · KXH
Ar Custom Medical Products, Ltd.
Radiology · 8d
Cleared Oct 10, 1986
HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS
K854236 · IAF
Nms Pharmaceuticals, Inc.
Chemistry · 354d
Cleared Oct 10, 1986
DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II
K863011
Sds Dental, Inc.
Dental · 63d
Cleared Oct 10, 1986
TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER
K863137 · DQO
Terumo Medical Corp.
Cardiovascular · 56d
Cleared Oct 10, 1986
TERUMO RADIFOCUS INTRODUCER KIT
K863139 · DYB
Terumo Medical Corp.
Cardiovascular · 56d
Cleared Oct 10, 1986
HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER
K863305 · LJT
C.R. Bard, Inc.
General Hospital · 46d