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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
158737–158760 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1983
VFS 1000/SCREENING FUNCTION ANALYZER
K830011 · HOX
CooperVision, Inc.
Ophthalmic · 14d
Cleared Jan 17, 1983
HEMA - NV TRANS. BLOOD FILTER 100/800
K830014 · CAK
Abbott Laboratories
General Hospital · 14d
Cleared Jan 14, 1983
ALTA II ECG RECORDER
K822362 · DSH
Scole Engineering Co.
Cardiovascular · 161d
Cleared Jan 14, 1983
CEMENTLESS ZWEYMUELLER HIP ENDOPROTHES
K822979 · JDI
Allo Pro Corp.
Orthopedic · 98d
Cleared Jan 14, 1983
PATHOLOGY INSTRUMENTATION & ACCESSORIES
K823040 · IBJ
Iris Remote Imaging Systems
Pathology · 92d
Cleared Jan 14, 1983
STRYKER CONSTAVAC
K823284 · GCY
Stryker Corp.
General & Plastic Surgery · 71d
Cleared Jan 14, 1983
SWITCHING UNIT ELECTRODE CATHETERS
K823361 · DRF
Webster Laboratories, Inc.
Cardiovascular · 66d
Cleared Jan 14, 1983
HANDI-TRAY
K823438 · FSM
Treace Medical, Inc.
General & Plastic Surgery · 59d
Cleared Jan 14, 1983
CLEAR CARDIOPLEJIA DELIVERY SYSTEM
K823451 · DTR
3M Health Care, Sarns
Cardiovascular · 58d
Cleared Jan 14, 1983
TOTAL IGE-FAST TEST
K823494 · DGC
Axonics, Inc.
Immunology · 52d
Cleared Jan 14, 1983
LIFELINE -UNIPOLAR LEAD #487-05
K823508 · DTB
Intermedics, Inc.
Cardiovascular · 49d
Cleared Jan 14, 1983
TOXI-LAB RAPID SCREEN
K823523 · DKJ
Marion Laboratories, Inc.
Toxicology · 46d
Cleared Jan 14, 1983
SUTTER CPM
K823539 · BXB
Sutter Biomedical, Inc.
Physical Medicine · 45d
Cleared Jan 14, 1983
EMG MODULES FOR POLYGRAPH SYSTEM
K823562 · IKN
Nihon Kohden America, Inc.
Neurology · 43d
Cleared Jan 14, 1983
HIGH FREQUENCY EPILATOR CB-2
K823674 · KCW
R. A. Fischer Co. Corp.
General & Plastic Surgery · 38d
Cleared Jan 14, 1983
CPM METABOLIC MONITOR
K823695 · BZL
Medicor USA , Ltd.
Anesthesiology · 37d
Cleared Jan 14, 1983
CYSTOFLO URINARY DRAINAGE BAG W/ANTIMIC
K823716 · KNX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 35d
Cleared Jan 14, 1983
EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR
K823733 · KOC
Advocacy International, Ltd.
Gastroenterology & Urology · 32d
Cleared Jan 14, 1983
CLEANING AGENT
K823750 · CHL
Shaban Mfg. Co.
Chemistry · 31d
Cleared Jan 14, 1983
EXTRACORPOREAL SUBCLAVIAN CATHETER KIT
K823752 · FIQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 31d
Cleared Jan 14, 1983
PRICK-TEST NEEDLE
K823760 · FMK
Cordis Corp.
General & Plastic Surgery · 31d
Cleared Jan 14, 1983
AMSCO ORTHOGRAPHIC 2 TABLE
K823772 · BWN
American Sterilizer Co.
General & Plastic Surgery · 31d
Cleared Jan 14, 1983
BORDON GAGE REGULATOR #BG
K823775 · CCN
Timeter Instrument Corp.
Anesthesiology · 31d
Cleared Jan 14, 1983
PI-PNEUMO-INTESTINAL INSTRUMENT SET
K823776 · GAG
Surgeons Choice, Inc.
General & Plastic Surgery · 30d