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

Filters: Cleared only ×
176,076 results
151753–151776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 1984
PHENYTOIN ACA ANALYTICAL TEST PACK
K843209 · DIP
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 57d
Cleared Oct 11, 1984
DK*300 VOLUMETRIC INFUSION CONTROLLER
K843254 · LDR
Deka Research & Development Corp.
General Hospital · 52d
Cleared Oct 11, 1984
DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP
K843305 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 49d
Cleared Oct 11, 1984
URI TX-100 MULTICHANNEL THERMOCOUPLE
K843381 · FLL
Uri Therm-X, Inc.
General Hospital · 44d
Cleared Oct 11, 1984
GAUDERER GASTROSTOMY BUTTON
K843392 · KNT
American V. Mueller
Gastroenterology & Urology · 43d
Cleared Oct 11, 1984
ENCORE TSH REAGENT
K843395 · JLW
Hybritech, Inc.
Chemistry · 43d
Cleared Oct 11, 1984
PROVIDER BAG SPIKE W/12 MICROBORE EXTEN
K843463 · FPA
Pancretec, Inc.
General Hospital · 36d
Cleared Oct 11, 1984
PHARMA-PLAST LEG BAG
K843479 · KNX
Zimmar Consulting , Ltd.
Gastroenterology & Urology · 35d
Cleared Oct 11, 1984
PHARMA-PLAST URINARY DRAINAGE BAG 2000
K843480 · KNX
Zimmar Consulting , Ltd.
Gastroenterology & Urology · 35d
Cleared Oct 11, 1984
ASTRA SYSTEMS AMYLASE REAGENT KIT
K843529 · CJA
Beckman Instruments, Inc.
Chemistry · 34d
Cleared Oct 11, 1984
TRIGLYCERIDE ASSAY KIT GPO-CP
K843536 · CDT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 34d
Cleared Oct 11, 1984
C-TERMINAL/MID-MOLECULE PARATHYROID -
K843685 · CEW
Nichols Institute Diagnostics
Chemistry · 23d
Cleared Oct 11, 1984
APPARATUS, SUCTION, WARD USE, PORTAB-
K843750 · BTA
H.C.H. Products, Inc.
General & Plastic Surgery · 16d
Cleared Oct 11, 1984
ALBUMIN REAGENT SET
K843831 · CIX
Livonia Diagnostics, Inc.
Chemistry · 10d
Cleared Oct 10, 1984
MICROELECTRODE
K842595 · GEI
Surgical Safety
General & Plastic Surgery · 99d
Cleared Oct 10, 1984
MICROPENCIL
K842596 · GEI
Surgical Safety
General & Plastic Surgery · 99d
Cleared Oct 10, 1984
INFANT MONITOR 16900
K843546 · BZQ
Healthdyne, Inc.
Anesthesiology · 30d
Cleared Oct 10, 1984
ECONO MATE
K843715 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 16d
Cleared Oct 10, 1984
BIOTIS BIGGY AGAR & BIGGY SLANT
K843761 · JSI
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS EMB-LEVINE AGAR
K843762 · JSI
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS EMB AGAR HOLT-HARRIS
K843763 · JSI
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS SCHAEDLER AGAR & BROTH
K843764 · JSG
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS MYCOBIOTIC AGAR
K843765 · JSJ
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS MYCOLOGICAL MEDIA & SLANT
K843766 · JSJ
Otisville Biotech, Inc.
Microbiology · 15d