Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
142681–142704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 10, 1986
URESIL OCCLUSION BALLOON CATHETER
K863559 · DQT
Uresil Corp.
Cardiovascular · 28d
Cleared Oct 10, 1986
URESIL IRRIGATION CATHETER
K863564 · DQY
Uresil Corp.
Cardiovascular · 28d
Cleared Oct 10, 1986
ENDOPHOTOCOAGULATION PROBE
K863591 · HQF
Mira, Inc.
Ophthalmic · 25d
Cleared Oct 10, 1986
POLAREX AND POLAREX MLD
K863651 · HQY
Selex, Inc.
Ophthalmic · 22d
Cleared Oct 10, 1986
PATHFINDER(TM) SPECIMEN COLLECTION KIT
K863682 · JSM
Kallestad Laboratories, Inc.
Microbiology · 21d
Cleared Oct 10, 1986
OPHTHALMIC FITLER MICRO CAPSULE
K863729 · HQC
Ipax, Inc.
Ophthalmic · 17d
Cleared Oct 09, 1986
DENTAL ANESTHESIA APPARATUS
K850425 · KZM
Pain Prevention, Inc.
Dental · 612d
Cleared Oct 09, 1986
PHONIC EAR, MODEL PE475R
K862773 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 79d
Cleared Oct 09, 1986
HOSPITAL BED
K863748 · FNJ
Global Medical Prods, Inc.
General Hospital · 15d
Cleared Oct 09, 1986
AMEBIASIS MICROASSAY
K863811 · KHW
Diamedix Corp.
Microbiology · 9d