FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134305–134328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 1988
FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT
K884031 · KIT
Regency Biotech
Pathology · 13d
Cleared Oct 06, 1988
BARD MULTI-TAC ECG MONITORING ELECTRODE
K884064 · DRX
C.R. Bard, Inc.
Cardiovascular · 10d
Cleared Oct 06, 1988
ACCI-GUARD(TM) REGULAR AND PEDIATRIC HOLDER
K884139 · FMI
Medical Safety Products, Inc.
General Hospital · 6d
Cleared Oct 05, 1988
POLY-TAC
K882235 · LDD
Cardiovascular Group, Inc.
Cardiovascular · 131d
Cleared Oct 05, 1988
SKINCOTE
K882567 · FRO
Dynarex Corp.
General & Plastic Surgery · 105d
Cleared Oct 05, 1988
TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5
K882904 · DRX
Tdk Corp.
Cardiovascular · 85d
Cleared Oct 05, 1988
MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM
K882966 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 82d
Cleared Oct 05, 1988
BREVET DENTAL INSTRUMENTS
K883126 · EKJ
Brevet, Inc.
Dental · 71d
Cleared Oct 05, 1988
PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR
K883965 · IYO
Teknar, Inc.
Radiology · 15d
Cleared Oct 04, 1988
OMRON DIGITAL FEVER THERMOMETER MODEL MC-3
K881415 · FLL
Omron Electronics, Inc.
General Hospital · 183d
Cleared Oct 04, 1988
TU STOPCOCK
K881805 · FMG
Tulan Corp. C/O Richard Hamer Assoc.
General Hospital · 159d
Cleared Oct 04, 1988
ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER
K881966 · DRF
C.R. Bard, Inc.
Cardiovascular · 146d
Cleared Oct 04, 1988
MEDICAL GLOVES STERILE LATEX SURGEONS DIGIFORM
K882595 · KGO
Marathon Management Co.
General Hospital · 102d
Cleared Oct 04, 1988
NON-CORING NEEDLES
K883009 · FMI
Quinton, Inc.
General Hospital · 77d
Cleared Oct 04, 1988
INSTAJECT II
K883164 · KZH
Pavel Jordan & Associates, Inc.
General Hospital · 69d
Cleared Oct 04, 1988
PMT VASCULAR CATHETER MODEL NUMBER 3621-1
K883313 · LJS
Pmt Corp.
General Hospital · 60d
Cleared Oct 04, 1988
VASCULON 2 INTRAVENOUS CANNULA
K883415 · FOZ
Ohmeda Medical
General Hospital · 50d
Cleared Oct 04, 1988
MEDALIST EXAMINATION TABLE
K883680 · LGX
Hamilton Industries, Inc.
General Hospital · 36d
Cleared Oct 04, 1988
BERNSCO NEEDLE ADAPTER
K883774 · GEI
Bernsco Surgical Supply, Inc.
General & Plastic Surgery · 28d
Cleared Oct 04, 1988
BERNSCO ELECTROSURGICAL SHIELD
K883823 · GEI
Bernsco Surgical Supply, Inc.
General & Plastic Surgery · 27d
Cleared Oct 04, 1988
MODEL CBX EPILATOR
K884079 · KCW
R. A. Fischer Co. Corp.
General & Plastic Surgery · 7d
Cleared Oct 03, 1988
DELFIA(TM) NEONATAL HTSH KIT
K881627 · JLW
Pharmacia, Inc.
Chemistry · 174d
Cleared Oct 03, 1988
A-SORB
K882115 · NAB
Howard Medical Co.
General & Plastic Surgery · 137d
Cleared Oct 03, 1988
VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM
K883582 · BTA
Surgidyne, Inc.
General & Plastic Surgery · 42d