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
124537–124560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 1990
SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET
K903969 · GAD
Karlin Technology, Inc.
General & Plastic Surgery · 8d
Cleared Sep 05, 1990
GENOX MODEL CT-1 OXYGEN/NITROGEN GENER-DISTR SYST
K904002 · CAW
Pacific Consolidated Industries
Anesthesiology · 7d
Cleared Sep 04, 1990
MEDI, CURI EXAM GLOVES
K893060 · LYY
Golden Charter , Ltd.
General Hospital · 509d
Cleared Sep 04, 1990
ZEROWET SPLASHIELD
K900208 · KYZ
Zerowet Splashield
General Hospital · 230d
Cleared Sep 04, 1990
TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)
K900331 · BZG
Ghg Medizin-Elektronik AG
Anesthesiology · 224d
Cleared Sep 04, 1990
SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI
K900472 · HBN
Skytron, Div. the Kmw Group, Inc.
Neurology · 216d
Cleared Sep 04, 1990
MAINZ HEAD FIXATION BY PERNECZKY
K901393 · HBL
Zeppelin GmbH
Neurology · 162d
Cleared Sep 04, 1990
ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND
K901657 · DXK
Hitachi Medical Corp. of America
Cardiovascular · 147d
Cleared Sep 04, 1990
ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND
K901658 · DXK
Hitachi Medical Corp. of America
Cardiovascular · 147d
Cleared Sep 04, 1990
PEEP VALVE
K902062 · BYE
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 119d
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