FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
150913–150936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 10, 1984
BIOTIS UREA AGAR
K843767 · JSI
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS KLIGLER IRON AGAR
K843768 · JSE
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS LOWENSTEIN-JENSEN MEDIA
K843769 · JSH
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS LYSINE IRON AGAR
K843770
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS SEVEN H 11 AGAR
K843771 · JSH
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Oct 10, 1984
BIOTIS MARTIN LEWIS AGAR
K843817 · JTY
Otisville Biotech, Inc.
Microbiology · 12d