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
155233–155256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1983
SERVOMED BASIC BEDSIDE UNIT - VARIOUS
K832024 · DRT
Litton Medical Electronics
Cardiovascular · 125d
Cleared Oct 26, 1983
SERVOMED BASIC BEDSIDE UNIT SMS 108 W/
K832026 · DRT
Litton Medical Electronics
Cardiovascular · 125d
Cleared Oct 26, 1983
SERVOMED STANDARD SMS 104
K832041 · DRT
Litton Medical Electronics
Cardiovascular · 124d
Cleared Oct 20, 1983
SILICONE-SILVER PENILE PROSTHESIS-ESK
K830667 · FTQ
Dacomed Corp.
Gastroenterology & Urology · 230d
Cleared Oct 20, 1983
CARDIOPLEGIA RECIRCULATION SYS-BL 705/A
K831458 · DWB
Electromedics, Inc.
Cardiovascular · 167d
Cleared Oct 20, 1983
TEMP. CARDIAC PACING WIRE TME 60/61/65
K831695 · LDF
Oscor, Inc.
Cardiovascular · 148d
Cleared Oct 20, 1983
LEAD INTRODUCER SETS-EB-S8 & EB-S12
K831751 · DYB
Oscor, Inc.
Cardiovascular · 141d
Cleared Oct 20, 1983
MULTIPOLAR TEMPORARY CARDIAC
K831804 · LDF
Oscor, Inc.
Cardiovascular · 139d
Cleared Oct 20, 1983
USCI ANGIOGRAPHIC BALLOON CATHETER
K831854 · DYG
C.R. Bard, Inc.
Cardiovascular · 133d
Cleared Oct 20, 1983
BLOOD OXYGENATOR 5070
K831894 · DTZ
Shiley, Inc.
Cardiovascular · 128d
Cleared Oct 20, 1983
IMPLANTABLE ENDOCARDIAL PACING LEADS
K831997 · DTB
Oscor, Inc.
Cardiovascular · 121d
Cleared Oct 20, 1983
SURGIKEK PENILE PROSTHESIS TAIL EXTEND
K832043 · FAE
Medical Engineering Corp.
Gastroenterology & Urology · 118d
Cleared Oct 20, 1983
ATAC 4700 HEMATOLOGY CELL COUNTER
K832116 · GIF
Turpen Laboratory Systems, Inc.
Hematology · 112d
Cleared Oct 20, 1983
ASPIRATOR
K832274 · BTA
Wells Johnson Co.
General & Plastic Surgery · 100d
Cleared Oct 20, 1983
INTRAMEDULLARY BONE PLUG
K832328 · JDS
Kirschner Medical Corp.
Orthopedic · 97d
Cleared Oct 20, 1983
HOLTA-MED RECORDER
K832395 · DSH
Holta-Med
Cardiovascular · 93d
Cleared Oct 20, 1983
HYPOTHERMIC MYCARDIAL PROTECTION DEV
K832417 · DTR
3M Health Care, Sarns
Cardiovascular · 91d
Cleared Oct 20, 1983
PLATELET AGGREGATION REAGENT SET
K832428 · GHR
Helena Laboratories
Hematology · 90d
Cleared Oct 20, 1983
AUTOMATIC ENDOSCOPE
K832458 · NVE
American Endoscopy, Inc.
General Hospital · 86d
Cleared Oct 20, 1983
PORTABLE LIFECARE VENTILATOR PLV-100
K832467 · CBK
Lifecare Services, Inc.
Anesthesiology · 79d
Cleared Oct 20, 1983
ASPIRATING TUBING
K832519 · GAZ
Wells Johnson Co.
General Hospital · 73d
Cleared Oct 20, 1983
SUCTION TIPS
K832520 · GEA
Wells Johnson Co.
General & Plastic Surgery · 73d
Cleared Oct 20, 1983
PLASTIC SUCTION TIPS
K832521 · GEA
Wells Johnson Co.
General & Plastic Surgery · 73d
Cleared Oct 20, 1983
MGI STRENGTH/FITNESS SYS-MODEL #PU-101
K832528 · JOM
Mgi Strength/Fitness Systems, Inc.
Cardiovascular · 93d