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
154513–154536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1983
SELECTO-DISC NOVOBIOCIN 5UG
K833407 · JTO
Lab Ability, Inc.
Microbiology · 91d
Cleared Dec 30, 1983
IMAGE INTENSIFIER TUBE W/HOUSING &
K833641 · JAA
Varian Assoc., Inc.
Radiology · 74d
Cleared Dec 30, 1983
TEE ADAPTER 9890-FLUSH WINDING 282
K833693 · JKS
Shaban Mfg. Co.
Chemistry · 73d
Cleared Dec 30, 1983
CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK
K833709 · JTN
General Diagnostics
Microbiology · 71d
Cleared Dec 30, 1983
ELASTIC BREATHABLE OVER-WRAP BANDAGE
K833729 · NAD
American Medical Disposable, Inc.
General & Plastic Surgery · 66d
Cleared Dec 30, 1983
BTI BIOX III OXIMETER CRITICAL CAREUNI
K833826 · DQA
Biox Technology, Inc.
Anesthesiology · 65d
Cleared Dec 30, 1983
HAEMOPHILUS IDENTIFICATION TEST KIT
K833963 · JTO
Remel Co.
Microbiology · 44d
Cleared Dec 30, 1983
10B
K833968 · JSN
Remel Co.
Microbiology · 44d
Cleared Dec 30, 1983
SABOURAUD DEXTROSE AGAR
K834008 · JSJ
Micro Media Laboratories
Microbiology · 39d
Cleared Dec 30, 1983
PVP IODINE
K834022 · JTO
Remel Co.
Microbiology · 38d
Cleared Dec 30, 1983
BIO-ORNITHINE
K834028 · JTO
Remel Co.
Microbiology · 38d
Cleared Dec 30, 1983
BIO-UREA
K834029 · JTO
Remel Co.
Microbiology · 38d
Cleared Dec 29, 1983
LOW TRAUMA ARTERIAL FILTER H-640
K831507 · DTM
C.R. Bard, Inc.
Cardiovascular · 232d
Cleared Dec 29, 1983
PLEURAL DRAINAGE SYS #PDS-100-4
K831849 · CAC
American Bentley
Hematology · 204d
Cleared Dec 29, 1983
JP-2 RESPIRATORY MONITORING SYSTEM
K832005 · CCK
Morgan Associates, Inc.
Anesthesiology · 189d
Cleared Dec 29, 1983
SOLUTION ADMIN. SET 2C9096 W/10 PVC
K832284 · FPA
Travenol Laboratories, S.A.
General Hospital · 169d
Cleared Dec 29, 1983
USE OF TWEEN 80 AS A WETTING AGENT ON
K832802 · DTN
American Bentley
Cardiovascular · 133d
Cleared Dec 29, 1983
FLOW-PAC GGT REAGENT SET
K833029 · JQB
American Research Products Co.
Chemistry · 113d
Cleared Dec 29, 1983
CENTRACATH #130,135 & 137-HEMOCATH #
K833079 · FOZ
Exco, Inc.
General Hospital · 111d
Cleared Dec 29, 1983
ONE TIME COMPOUND BENZOIN TINCTURE-
K833120 · KGX
Acme United Corp.
General & Plastic Surgery · 107d
Cleared Dec 29, 1983
ACRA-CUT
K833266 · HBF
Acra Cut, Inc.
Neurology · 99d
Cleared Dec 29, 1983
C & B 45
K833278 · EIS
Genesis Industries, Inc.
Dental · 98d
Cleared Dec 29, 1983
C & B 61 PENTRON C & B61
K833289 · EIS
Genesis Industries, Inc.
Dental · 98d
Cleared Dec 29, 1983
PHYSIO-PROBE-HIGH PERMEABILITY CATH.
K833433 · DQY
Research Industries Corp.
Cardiovascular · 85d