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
157969–157992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1983
S & W MODEL 29
K830875 · JFB
S & W Enterprises, Inc.
Physical Medicine · 21d
Cleared Apr 08, 1983
H-H IN-LINE VALVED CATHETER 2 TYPES
K830894 · JXG
Holter-Hausner Intl.
Neurology · 18d
Cleared Apr 08, 1983
PLAYTEX TAMPONS
K830966 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 11d
Cleared Apr 06, 1983
ASPITRON
K823088 · HQC
Intl. Ophthalmic Industries Corp.
Ophthalmic · 169d
Cleared Apr 06, 1983
GLUCOSE REAGENT
K823537 · FMF
Ac Biochemical Laboratories, Inc.
Chemistry · 127d
Cleared Apr 06, 1983
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13
K823585 · DSI
Brentwood Instruments, Inc.
Cardiovascular · 121d
Cleared Apr 06, 1983
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200
K823586 · DSI
Brentwood Instruments, Inc.
Cardiovascular · 121d
Cleared Apr 06, 1983
EXTENSION HANDLE FOR ACUTOME PROBE
K830037 · HQE
Precision Medical Instruments, Inc.
Ophthalmic · 89d
Cleared Apr 06, 1983
ODONTIC CENTRIC(BITE) REGIST. PASTE
K830044 · ELW
Wallace A. Erickson & Co.
Dental · 89d
Cleared Apr 06, 1983
FLORET OPHTHALMIC EYE SPEAR
K830262 · HOZ
Ritmed, Inc.
Ophthalmic · 71d
Cleared Apr 06, 1983
REPLAM HYDROXYAPATITE
K830304 · LYC
Replam Corp.
Dental · 68d
Cleared Apr 06, 1983
ESOPHAGEAL PROBE W/TEMP. INDICATOR
K830353 · FLL
Science Development Corp.
General Hospital · 62d
Cleared Apr 06, 1983
PROVIDONE-IODINE SWABSTICKS
K830393 · GEC
H & P Industries, Inc.
General & Plastic Surgery · 58d
Cleared Apr 06, 1983
PROVIDONE-IODINE PREP-PADS & TOWELETTES
K830394 · GEC
H & P Industries, Inc.
General & Plastic Surgery · 58d
Cleared Apr 06, 1983
SYN-02 PN AMPLIFIER
K830421 · FFX
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 06, 1983
TEMP TRACE
K830530 · FLL
Progress Mankind Technology
General Hospital · 47d
Cleared Apr 06, 1983
DENTAL PORCELAIN POWDER
K830553 · EIH
Dentsply Intl.
Dental · 42d
Cleared Apr 06, 1983
ENSURE DRESSING
K830593 · NAD
Warner-Lambert Co.
General & Plastic Surgery · 41d
Cleared Apr 06, 1983
COBE RX METER
K830629 · FLB
Cobe Laboratories, Inc.
Gastroenterology & Urology · 36d
Cleared Apr 06, 1983
URIC ACID COLORIMETRIC DETERMINATION
K830679 · KNK
Dow Instruments & Reagents, Inc.
Chemistry · 33d
Cleared Apr 06, 1983
TDX THYROXINE
K830683 · KLI
Abbott Laboratories
Chemistry · 33d
Cleared Apr 06, 1983
MMH PTH RIA KIT
K830700 · CEW
Diagnostic Systems
Chemistry · 30d
Cleared Apr 06, 1983
TOTAL BILIRUBIN REAGENT
K830714 · CIG
Hi Chem, Inc.
Chemistry · 29d
Cleared Apr 06, 1983
KEMTEK 102
K830751 · JJJ
Kemble Instruments, Inc.
Chemistry · 27d