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
122497–122520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1991
INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT
K902628 · DXG
Biometric Research Institute, Inc.
Cardiovascular · 257d
Cleared Feb 25, 1991
PCM ANESTHESIA
K903991 · BSZ
Siemens Life Support Systems
Anesthesiology · 180d
Cleared Feb 25, 1991
SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.
K904117 · BZG
Dawn Medical
Anesthesiology · 172d
Cleared Feb 25, 1991
SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.
K904118 · BZG
Dawn Medical
Anesthesiology · 172d
Cleared Feb 25, 1991
MODEL 4222 AMBULATORY ECG MONITOR
K904250 · DXH
Byrncrest Global, Inc.
Cardiovascular · 161d
Cleared Feb 25, 1991
EER ERECTION ENHANCED RESPONDER
K904406 · LKY
Eer, Inc.
Gastroenterology & Urology · 154d
Cleared Feb 25, 1991
QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE
K904582 · DQX
Meadox Surgimed, Inc.
Cardiovascular · 139d
Cleared Feb 25, 1991
VISTA VIEWING STATION
K904975 · DXK
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
CINE'VIEW - STRESS ECHO & IMAGE REVIEW
K904976 · DXK
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
CINE/VIEW PLUS - CARDIOLOGY WORKSTATION
K904977 · DXK
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
SOFTWARE PROGRAM USED W/PRISM PRODUCTS
K904978 · DXK
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER
K905139 · DXE
Cathlab Corp.
Cardiovascular · 108d
Cleared Feb 25, 1991
EUB-315
K905294 · IYO
Hitachi Medical Corp. of America
Radiology · 90d
Cleared Feb 25, 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE
K905548 · DQX
Mallinckrodt Medical
Cardiovascular · 76d
Cleared Feb 25, 1991
SARNS TEMPERATURE PROBE AND CONNECTOR
K905686 · DWE
3M Health Care, Sarns
Cardiovascular · 68d
Cleared Feb 25, 1991
PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES)
K905765 · LYY
Tillotson Rubber Co., Inc.
General Hospital · 60d
Cleared Feb 25, 1991
MRP -5000(1): VERSION 2.0 SOFTWARE
K905832 · LNH
Summit World Trade Corp.
Radiology · 56d
Cleared Feb 25, 1991
MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY
K905833 · LNH
Summit World Trade Corp.
Radiology · 56d
Cleared Feb 25, 1991
BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR
K910112 · DTD
Telectronics Pacing Systems, Inc.
Cardiovascular · 46d
Cleared Feb 25, 1991
LP-60 LOW PRESSURE INFLATION DEVICE
K910205 · MAV
Devices For Vascular Intervention, Inc.
Cardiovascular · 40d
Cleared Feb 25, 1991
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237 · DTE
Medtronic Vascular
Cardiovascular · 38d
Cleared Feb 25, 1991
ANTIMICROBIAL CEFOPERAZONE
K910345 · JWY
Alamar
Microbiology · 28d
Cleared Feb 25, 1991
ANTIMICROBIAL CEFTRIAXONE
K910346 · JWY
Alamar
Microbiology · 28d
Cleared Feb 25, 1991
FOXELL PLUS MULTIPLE (PERSONAL TOUCH TM)
K910439 · LYY
Lowenkamp Intl., Inc.
General Hospital · 25d