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
141841–141864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 1987
BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1
K864823 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 06, 1987
MODEL 5866-24 PACEMAKER LEAD ADAPTOR
K864856 · DTB
Medtronic Vascular
Cardiovascular · 26d
Cleared Jan 06, 1987
ICU/CPU TRANSPORT TRAY
K864878 · FNJ
Orthopedic Systems, Inc.
General Hospital · 25d
Cleared Jan 05, 1987
METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME
K853952 · DPW
Metriflow, Inc.
Radiology · 467d
Cleared Jan 05, 1987
1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER
K861205 · DSB
Valhalla Scientific
Cardiovascular · 280d
Cleared Jan 05, 1987
EUB-310 ULTRASONIC SCANNER
K862867 · IYO
Hitachi Medical Corp. of America
Radiology · 160d
Cleared Jan 05, 1987
DALTEX IV INFUSION PUMP
K863470 · FRN
Daltex Medical Sciences, Inc.
General Hospital · 119d
Cleared Jan 05, 1987
IL TEST 97575-15, HEPARIN ASSAY
K864211 · KFF
Instrumentation Laboratory CO
Hematology · 69d
Cleared Jan 05, 1987
ABBOTT SPECTRUM GLUCOSE REAGENT
K864224 · CGA
Abbott Laboratories
Chemistry · 69d
Cleared Jan 05, 1987
DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY
K864333 · KXT
Windsor Laboratories, Inc.
Toxicology · 62d
Cleared Jan 05, 1987
PROTIME AUTOMATE TEST KIT
K864392 · GJS
American Bioproducts Co.
Hematology · 60d
Cleared Jan 05, 1987
COAGULATION INTRINSIC DEFICIENT PLASMAS
K864481 · GGP
Instrumentation Laboratory CO
Hematology · 53d
Cleared Jan 05, 1987
COAGULATION EXTRINSIC DEFICIENT PLASMAS
K864497 · GGP
Instrumentation Laboratory CO
Hematology · 52d
Cleared Jan 05, 1987
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE
K864646 · GKF
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 41d
Cleared Jan 05, 1987
AM CATH ESWL STENT
K864669 · FAD
Inter-Med Corp.
Gastroenterology & Urology · 34d
Cleared Jan 05, 1987
MICRODILUTION IDENTIFICATION PANELS
K864674 · JSE
American Micro Scan
Microbiology · 34d
Cleared Jan 05, 1987
RAICHEM(TM) AMMONIA REAGENT
K864706 · JIF
Reagents Applications, Inc.
Chemistry · 34d
Cleared Jan 05, 1987
CULT-UR
K864727 · LIO
R.P. Laboratories, Inc.
Microbiology · 34d
Cleared Jan 05, 1987
LKB 2260 MACROTOME
K864733 · IDO
Lkb Instruments, Inc.
Pathology · 32d
Cleared Jan 05, 1987
BONE MARROW COLLECTION MEDIUM
K864740 · KIT
Bioclinical Laboratory Services, Inc.
Pathology · 32d
Cleared Jan 05, 1987
PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM
K864755 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 31d
Cleared Jan 05, 1987
S&W MODEL HIGH-LOW MAT TABLE, VARIOUS MODELS
K864817 · INQ
S & W Enterprises, Inc.
Physical Medicine · 27d
Cleared Jan 05, 1987
SUNTANNING LAMP
K864907 · FTC
Interlectric Corp.
General & Plastic Surgery · 21d
Cleared Jan 05, 1987
TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY
K864945 · JFH
Hybritech, Inc.
Chemistry · 19d