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
141865–141888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 1987
ULTRASOUND TRANSDUCER ASSEMBLY
K862211 · ITX
Johnson & Johnson Professionals, Inc.
Radiology · 206d
Cleared Jan 02, 1987
MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
K862459 · DXY
Medtronic Vascular
Cardiovascular · 186d
Cleared Jan 02, 1987
VEIN VALVE CUTTER
K862724 · DQY
American Edwards Laboratories
Cardiovascular · 169d
Cleared Jan 02, 1987
2200I PHYSIOLOGICAL MONITOR
K863308 · DXG
Datascope Corp.
Cardiovascular · 130d
Cleared Jan 02, 1987
EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER
K864007 · DXE
Uresil Corp.
Cardiovascular · 79d
Cleared Jan 02, 1987
BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600
K864235 · DTZ
C.R. Bard, Inc.
Cardiovascular · 66d
Cleared Jan 02, 1987
ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING
K864262 · DTM
Johnson & Johnson Professionals, Inc.
Cardiovascular · 65d
Cleared Dec 31, 1986
MAGNESIOMETER
K863069 · JGJ
J. D. Assoc.
Chemistry · 141d
Cleared Dec 31, 1986
DERMATEC TRANSPARENT FILM DRESSING
K863580 · NAD
Dermatec, Inc.
General & Plastic Surgery · 125d
Cleared Dec 31, 1986
SYNCHRON CX3
K864236 · JJF
Beckman Instruments, Inc.
Chemistry · 64d
Cleared Dec 31, 1986
QKO (TM) AMYLASE B-HA
K864303 · JFJ
Wako Chemicals USA, Inc.
Chemistry · 61d
Cleared Dec 31, 1986
AP1 COLORIMETER
K864634 · JJQ
Awareness Technology, Inc.
Chemistry · 36d
Cleared Dec 31, 1986
CHLORIDE REAGENT
K864713 · CHJ
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 31, 1986
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
K864715 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Dec 31, 1986
A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS
K864776 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 23d
Cleared Dec 31, 1986
ALANINE AMINO TRANSFERASE ALT/SGPT
K864906 · CKA
Tech-Co, Inc.
Chemistry · 16d
Cleared Dec 31, 1986
BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT
K864939 · CDT
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Dec 30, 1986
MEDSURG VASCULAR ACCESS PORT INFUSION TRAY
K864495
Medsurg Industries, Inc.
General & Plastic Surgery · 46d
Cleared Dec 30, 1986
PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME
K864570 · HIS
Dongkuk Techco Rubber Industries
Obstetrics & Gynecology · 40d
Cleared Dec 30, 1986
ELLISON ARTHROSCOPY CHEATER
K864892 · HRX
Buckman Co., Inc.
Orthopedic · 15d
Cleared Dec 29, 1986
HYDROXYLAPATITE BONE GRAFT MATERIAL
K863237 · LYC
Richards Medical Co., Inc.
Dental · 130d
Cleared Dec 29, 1986
FMS MODEL 110
K863736 · IYM
Flir Medical Systems
Radiology · 97d
Cleared Dec 29, 1986
ADA-1000 (ADVANCED DIGITAL ARRAY)
K863780 · IYO
Diasonics, Inc.
Radiology · 94d
Cleared Dec 29, 1986
MLC ENDOTHELIAL CELL COUNTER
K863970 · HJO
Mlc Technologies
Ophthalmic · 76d