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
152401–152424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 1984
FLASH GUARD
K841669
Sparco, Inc.
General & Plastic Surgery · 43d
Cleared Jun 05, 1984
LCI MEDICAL INC AIR/PAL
K841728 · FRZ
Lehigh Consolidated Industries
General Hospital · 41d
Cleared Jun 05, 1984
LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM
K841732 · IZP
Sybron Corp.
Radiology · 40d
Cleared Jun 05, 1984
IMPULSE VENTILATOR
K841818 · CBK
Healthdyne, Inc.
Anesthesiology · 35d
Cleared Jun 05, 1984
HPD HUMIDIFIER WICK
K841851 · BTT
Hpd Medical, Inc.
Anesthesiology · 33d
Cleared Jun 05, 1984
THREE WAY INFUSION SET
K841882 · FPA
Med Fusion Systems, Inc.
General Hospital · 29d
Cleared Jun 05, 1984
SURGEON'S BLADES STERILE BLADE
K841883 · GES
An-Med Intl.
General & Plastic Surgery · 29d
Cleared Jun 05, 1984
VMT HAND HELD NEBULIZER
K841894 · CCQ
Vortran Medical Technology 1, Inc.
Anesthesiology · 29d
Cleared Jun 05, 1984
DUPONT ACA LIQUID BILIRUBIN CALIBRATOR
K842222
E.I. Dupont DE Nemours & Co., Inc.
Chemistry
Cleared Jun 04, 1984
HEPARIN LOCK FLUSH PROCEDURE PACK
K841166 · FMI
Solo Pak Laboratories
General Hospital · 77d
Cleared Jun 04, 1984
SUCTION CANNULAS
K841249 · GEA
Custom Surgical Products, Inc.
General & Plastic Surgery · 75d
Cleared Jun 04, 1984
HEPARIN LOCK FLUSH SOLUTION USP KIT
K841305 · FMI
Solo Pak Laboratories
General Hospital · 66d
Cleared Jun 04, 1984
HEPARIN LOCK FLUSH SOLUTION USP KIT,100
K841306 · FMI
Solo Pak Laboratories
General Hospital · 66d
Cleared Jun 01, 1984
SERVOMED BASIC BEDSIDE UNIT SMA 102-
K832250 · DRT
Litton Medical Electronics
Cardiovascular · 326d
Cleared Jun 01, 1984
2-CHANNEL RECORDER
K832998 · DSF
Litton Medical Electronics
Cardiovascular · 288d
Cleared Jun 01, 1984
I-CHANNEL RECORDER
K833000 · DSF
Litton Medical Electronics
Cardiovascular · 288d
Cleared Jun 01, 1984
EXTENSION BOX EB200
K834530 · DRT
Honeywell, Inc.
Cardiovascular · 163d
Cleared Jun 01, 1984
RECOMB ECG PREAMPLIFIER/206 069 03
K834600 · DRT
Litton Medical Electronics
Cardiovascular · 154d
Cleared Jun 01, 1984
SWISS OPTICAL PRODUCTS-CONTACT CASE
K840115 · HQD
Moonbeam International, Inc.
Ophthalmic · 142d
Cleared Jun 01, 1984
SERVOMED DIGITAL DISPLAY MODULE
K840521 · DRT
Litton Medical Electronics
Cardiovascular · 115d
Cleared Jun 01, 1984
SERVOMED COMPACT MONITOR SMK 155-1/101
K840525 · DRT
Litton Medical Electronics
Cardiovascular · 115d
Cleared Jun 01, 1984
GORE-TEX CATHETER
K840864 · KNT
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 95d
Cleared Jun 01, 1984
CONTACT LENS INSERTER/REMOVER
K841163 · HQD
Optimum Manufacturers, Inc.
Ophthalmic · 74d
Cleared Jun 01, 1984
DIA REPTIN
K841365 · GIR
Diatech, Inc.
Hematology · 60d