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
144673–144696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1986
SERVO GAS MONITOR 120
K861625 · CCL
Siemens Elema AB
Anesthesiology · 3d
Cleared May 01, 1986
FORAN CORP-SURESERT INTRAVENOUS CATHETER PLACE UNI
K853988 · FOZ
Foran Industries, Inc.
General Hospital · 216d
Cleared May 01, 1986
DCI MODEL EP-2 CLINICAL STIMULATOR
K854196 · DRO
Digital Cardiovascular Instruments, Inc.
Cardiovascular · 198d
Cleared May 01, 1986
CORDOT R
K854618 · LFX
Cordis Corp.
Microbiology · 164d
Cleared May 01, 1986
INFAGUARD TM
K854705 · BZQ
Lifewatch Systems, Inc.
Anesthesiology · 161d
Cleared May 01, 1986
GREEN-LINE BIPOLAR COAGULATION UNIT
K860479 · GEI
Grieshaber & Co.
General & Plastic Surgery · 83d
Cleared May 01, 1986
VMA BY HPLC TEST (VANILMANDELIC ACID)
K861010 · CDF
Bio-Rad
Chemistry · 44d
Cleared May 01, 1986
SPECTRO VWF
K861159 · GGP
Ramco Laboratories, Inc.
Hematology · 34d
Cleared May 01, 1986
MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG
K861434 · LHI
Churchill Corp.
General Hospital · 14d
Cleared Apr 30, 1986
KOI PACHYMETER
K843247 · ITX
Koi, Inc.
Radiology · 618d
Cleared Apr 30, 1986
PAINBLOCKER WA5000
K854334 · GXH
Wallach Surgical Devices, Inc.
Neurology · 184d
Cleared Apr 30, 1986
ELECTROCARDIOGRAPH CONTINUOUS MONITOR
K860457 · GWN
Oxford Medilog, Inc.
Neurology · 84d
Cleared Apr 30, 1986
DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST
K860470 · DSI
Del Mar Avionics
Cardiovascular · 83d
Cleared Apr 30, 1986
DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER
K860471 · DSI
Del Mar Avionics
Cardiovascular · 83d
Cleared Apr 30, 1986
ETP 180 CARDIAC PACEMAKER (EXTERNAL)
K860551 · DRO
Biotronics Corp.
Cardiovascular · 76d
Cleared Apr 30, 1986
HEARTSTART 2000
K860676 · MKJ
First Medical Devices Corp.
Cardiovascular · 64d
Cleared Apr 30, 1986
FACEGLOV,ANESTHETIC GAS MASK
K860686 · BSJ
Loran , Ltd.
Anesthesiology · 64d
Cleared Apr 30, 1986
ZEISS VOICE CONTROL SYSTEM FOR OPMI'S
K860811 · EPT
Carl Zeiss, Inc.
General & Plastic Surgery · 57d
Cleared Apr 30, 1986
OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH
K861083 · LYC
Coors Biomedical Co.
Dental · 40d
Cleared Apr 30, 1986
OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH
K861084 · LYC
Coors Biomedical Co.
Dental · 40d
Cleared Apr 30, 1986
BISCO'S PORCELAIN VENEER SYSTEM
K861148 · EBF
Bisco, Inc.
Dental · 35d
Cleared Apr 30, 1986
STERILE STOCKINETTE W/ANTIMICROBIAL AGENT
K861196 · KKX
Deroyal Industries, Inc.
General Hospital · 30d
Cleared Apr 30, 1986
DIALET LANCING DEVICE
K861265 · FMK
Home Diagnostics, Inc.
General & Plastic Surgery · 26d
Cleared Apr 30, 1986
ISOTRAK AMYLASE ISOENZYME CONTROL SET
K861329 · JJT
Behring Diagnostics, Inc.
Chemistry · 21d