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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
111817–111840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1993
MICRO MIST(TM) NEBULIZER
K930525 · CAF
Hudson Respiratory Care, Inc.
Anesthesiology · 239d
Cleared Sep 29, 1993
MRINNERVU DISPOSABLE ENDORECTAL COLON COIL,#PCC-15
K930544 · LNH
Medrad, Inc.
Radiology · 239d
Cleared Sep 29, 1993
CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT
K930553 · EWO
Etymotic Research
Ear, Nose, Throat · 238d
Cleared Sep 29, 1993
LATEX EXAMINATION GLOVES, POWDER FREE
K930602 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 239d
Cleared Sep 29, 1993
ANTHOS HT READERS, INCLUDING THE ANTHOS HT II&III
K931907 · JJQ
Anthos Labtec Instruments
Chemistry · 167d
Cleared Sep 29, 1993
MONOJECT(R) MONOLETTOR SAFETY LANCET
K932785 · FMK
Sherwood Medical Co.
General & Plastic Surgery · 112d
Cleared Sep 29, 1993
AUTO SUTURE ENDOSCOPIC INSTRUMENT CLAMP
K932885 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 107d
Cleared Sep 29, 1993
ALPHA-DENT LIGHT ACTIVATED CORE BUILDUP BLUE PASTE
K932886 · EBF
Wallace A. Erickson & Co.
Dental · 107d
Cleared Sep 29, 1993
ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP
K932990 · EFB
Oral-B Laboratories
Dental · 103d
Cleared Sep 29, 1993
DW247 #2
K933083 · EJT
Ivoclar North America, Inc.
Dental · 98d
Cleared Sep 29, 1993
DW 248 #46
K933186 · EJT
Ivoclar North America, Inc.
Dental · 91d
Cleared Sep 29, 1993
EXA BITE REGISTRATION MATERIAL
K933206 · ELW
GC America, Inc.
Dental · 90d
Cleared Sep 29, 1993
VISIONTOOL
K933209 · LLZ
Evergreen Technologies, Inc.
Radiology · 90d
Cleared Sep 28, 1993
EDGE SYRINGES AND NEEDLES
K923321 · FMF
Trico Intl., Inc.
General Hospital · 448d
Cleared Sep 28, 1993
CFM-800 COLOR FLOW MAPPING SYSTEM
K924079 · IYO
Diasonics, Inc.
Radiology · 411d
Cleared Sep 28, 1993
SURFAS
K925081 · ITX
D.O. Weaver and Co.
Radiology · 356d
Cleared Sep 28, 1993
TECHMEDICA STANDARD BIPOLAR SYSTEM
K925420 · KWY
Techmedica, Inc.
Orthopedic · 336d
Cleared Sep 28, 1993
PARI FILTER/VALVE SET
K926455 · CAF
Paul Ritzau Pari-Werk GmbH
Anesthesiology · 278d
Cleared Sep 28, 1993
ULTRA COMPACT VIDEO IMAGER
K930755 · LMC
International Imaging Electronics
Radiology · 228d
Cleared Sep 28, 1993
INTHERM STASIS VALVE SYSTEM
K931025 · FGE
Interventional Therapeutics Corp.
Gastroenterology & Urology · 211d
Cleared Sep 28, 1993
TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER
K931201 · OCX
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 203d
Cleared Sep 28, 1993
MICROTAINER BRAND TUBE WITH EDTA
K931368 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 195d
Cleared Sep 28, 1993
MODIFIED LUER
K931833 · DQO
Medi-Dyne, Inc.
Cardiovascular · 204d
Cleared Sep 28, 1993
AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS
K932408 · FFN
Baxter Healthcare Corp
Gastroenterology & Urology · 133d