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
125137–125160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1990
SILVER MACTRODE
K902176 · DRX
Marquette Electronics, Inc.
Cardiovascular · 112d
Cleared Sep 04, 1990
LM-1Z ZOOM SCOPE
K902313 · HEX
Leisegang Medical, Inc.
Obstetrics & Gynecology · 104d
Cleared Sep 04, 1990
MONOSCOPY(TM) BRAND, TROCAR REDUCER SET
K902563 · HET
Dexide, Inc.
Obstetrics & Gynecology · 85d
Cleared Sep 04, 1990
ALASTAT ALLERGEN-SPEC IGE CONTROL DC1A/2A/6A/NGCA
K902576 · DHB
Diagnostic Products Corp.
Immunology · 85d
Cleared Sep 04, 1990
GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS
K902632 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 82d
Cleared Sep 04, 1990
PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)
K902716 · DQK
Prucka Engineering, Inc.
Cardiovascular · 76d
Cleared Sep 04, 1990
ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH
K902738 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 75d
Cleared Sep 04, 1990
.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP
K902755 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 74d
Cleared Sep 04, 1990
FETAL MONITORING TRANSDUCER STRAP
K902802 · HGM
Macon & Co., Inc.
Obstetrics & Gynecology · 88d
Cleared Sep 04, 1990
COOK CORONARY GUIDING CATHETER
K902905 · DQY
Cook, Inc.
Cardiovascular · 64d
Cleared Sep 04, 1990
LIFELOG(TM)
K902962 · BSZ
Modular Instruments, Inc.
Anesthesiology · 61d
Cleared Sep 04, 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE
K903125 · BYE
Puritan Bennett Corp.
Anesthesiology · 50d
Cleared Sep 04, 1990
BIOCHEM 6100 NON-INVASIVE MONITOR
K903222 · DXN
Biochem International, Inc.
Cardiovascular · 43d
Cleared Sep 04, 1990
MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE
K903422 · IXR
Imt America, Inc.
Radiology · 35d
Cleared Sep 04, 1990
LAPAROSCOPE
K903528 · HET
Intramed Laboratories, Inc.
Obstetrics & Gynecology · 29d
Cleared Sep 04, 1990
PUCK 90M
K903576 · KPX
Elema-Schonander, Inc.
Radiology · 27d
Cleared Sep 04, 1990
MODEL 610 MODIFIED
K903657 · LDD
First Medical Devices Corp.
Cardiovascular · 26d
Cleared Sep 04, 1990
PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM
K903699 · JOH
Passy & Passy, Inc.
Anesthesiology · 20d
Cleared Sep 04, 1990
AVI MICRO 285CM INFUSION PUMP
K903788 · FRN
3M Avi, Inc.
General Hospital · 15d
Cleared Sep 04, 1990
VENTLAB VENT-MASK, CAT# VR 0010/20/30
K903881 · BSJ
Ventlab Corp.
Anesthesiology · 13d
Cleared Aug 31, 1990
PIEZON MASTER 400
K896749 · ELC
Electro Medical Systems (Ems Sa)
Dental · 274d
Cleared Aug 31, 1990
SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND
K900683 · ITX
Hitachi Medical Corp. of America
Radiology · 199d
Cleared Aug 31, 1990
F-20 CEMENTED METAL-BACKED ACETABULAR CUP
K901451 · JDI
Med-Tek Corp.
Orthopedic · 151d
Cleared Aug 31, 1990
CHALLENGE 7010 POWERED MUSCLE STIMULATOR
K902511 · IPF
Maximum Performance Technologies,...
Physical Medicine · 87d