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
152713–152736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1984
CEFONICID 30 MCG SENSITIVITY DISCS
K842292 · JTN
Difco Laboratories, Inc.
Microbiology · 45d
Cleared Jul 26, 1984
DELTON * OPAQUE LIGHT CURING PIT
K842392 · EBC
Johnson & Johnson Professionals, Inc.
Dental · 38d
Cleared Jul 26, 1984
DUO FLOW CATHETER-MC 54
K842416 · KNZ
Medical Components, Inc.
Gastroenterology & Urology · 36d
Cleared Jul 26, 1984
RAPID PLASMA REAGIN CARD TEST
K842541 · GMQ
Clinical Sciences, Inc.
Microbiology · 24d
Cleared Jul 26, 1984
STAR HCG MONOCLONAL ANTIBODY IMMUNO
K842598 · JHI
Syncor Intl. Corp.
Chemistry · 35d
Cleared Jul 26, 1984
SUPER PETAL SOFT PLASTIC APPLICATOR TAMP
K842618 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 21d
Cleared Jul 26, 1984
REGULAR PETAL SOFT PLASTIC APPLICATOR
K842619 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 21d
Cleared Jul 26, 1984
STERELIS SEALING EQUIPMENT
K842631 · FLE
Sterelis Corp.
General Hospital · 20d
Cleared Jul 26, 1984
BEAR JET-150 VENTILATOR
K842688 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 16d
Cleared Jul 26, 1984
LUNG ANALYZER CM-310
K842760 · BZC
Cybermedic, Inc.
Anesthesiology · 10d
Cleared Jul 26, 1984
AVATRON UNIVERSAL ADULT VOL. VENTILATOR
K842778 · BZO
Avatron, Inc.
Anesthesiology · 10d
Cleared Jul 25, 1984
UMBILICAL VESSEL CATHETER
K840339 · FOS
Catheter Technology Corp.
General Hospital · 182d
Cleared Jul 25, 1984
IVENT 302VC DUAL CONTROLLER
K842210 · LDR
Ivent Corp.
General Hospital · 51d
Cleared Jul 25, 1984
CLINITEK 10 SEMI-AUTO URINALYSIS SYS
K842238 · KQO
Miles Laboratories, Inc.
Chemistry · 50d
Cleared Jul 25, 1984
MTP E.V. INFUSION PUMP
K842263 · FRN
Ziehm International, Inc.
General Hospital · 48d
Cleared Jul 25, 1984
SR- MODEL 230
K842289 · FRN
Hirata Sangyo Co. USA, Inc.
General Hospital · 47d
Cleared Jul 25, 1984
CHEMISTRY ANALYZER, GEN. PURPOSE
K842311 · JJQ
Hml Inc/Biotechnology Transfer
Chemistry · 43d
Cleared Jul 25, 1984
SYVA IQ 190 DIGITAL PIPETTER DILUTER
K842390 · JQW
Syva Co.
Toxicology · 37d
Cleared Jul 25, 1984
AXIOM STABLE II CHOLESTEROL TEST
K842441 · CHH
Axiom, Inc.
Chemistry · 34d
Cleared Jul 25, 1984
SHERIDAN/ENDO-PAK
K842635 · BTR
Sheridan Catheter Corp.
Anesthesiology · 16d
Cleared Jul 25, 1984
HYDRO/BUBBLE BATH DEVICE 300
K842641 · ILJ
Heddernheimer Metallwarenfabrik GmbH
Physical Medicine · 15d
Cleared Jul 25, 1984
BALSAN 700
K842642 · ILJ
Heddernheimer Metallwarenfabrik GmbH
Physical Medicine · 15d
Cleared Jul 25, 1984
MASSAPED
K842643 · ILJ
Heddernheimer Metallwarenfabrik GmbH
Physical Medicine · 15d
Cleared Jul 25, 1984
STANDARD WHEELCHAIR
K842719 · IQC
Greene International Corp.
Physical Medicine · 12d