FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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

Filters: Cardiovascular ×
18,151 results
10777–10800 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 26, 1995
SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER
K952885 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 95d
Cleared Sep 25, 1995
MEDRAD SPECTRIS MR INJECTOR
K935668 · DXT
Medrad, Inc.
Cardiovascular · 668d
Cleared Sep 25, 1995
FASGUIDE
K951159 · DQY
Target Therapeutics
Cardiovascular · 195d
Cleared Sep 21, 1995
PRECEDER GUIDEWIRE
K953023 · DQX
Boston Scientific Corp
Cardiovascular · 84d
Cleared Sep 20, 1995
RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR
K941252 · DRT
Ansar
Cardiovascular · 554d
Cleared Sep 19, 1995
LIFE SOUND SENSOR
K952651 · DQC
Flowscan, Inc.
Cardiovascular · 102d
Cleared Sep 19, 1995
SCIMED TRIGUIDE GUIDE CATHETERS
K953515 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 55d
Cleared Sep 18, 1995
EPICARDIA
K952846 · DQK
Medicomp, Inc.
Cardiovascular · 89d
Cleared Sep 18, 1995
AUSCULATOR GPS
K953218 · DQD
Lyte Industries, Inc.
Cardiovascular · 70d
Cleared Sep 15, 1995
DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
K950440 · DQO
J-Lloyd Medical, Inc.
Cardiovascular · 231d
Cleared Sep 15, 1995
CARDIO SERV
K951110 · LDD
Hellige GmbH
Cardiovascular · 189d
Cleared Sep 15, 1995
CUFF GUARD
K952825 · DXQ
Bowen Medical Services, Inc.
Cardiovascular · 87d
Cleared Sep 15, 1995
GENERICUFF
K953466 · DXQ
Generic Medical, Inc.
Cardiovascular · 53d
Cleared Sep 13, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM
K950479 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 222d
Cleared Sep 12, 1995
BAIR HUGGER MODEL 655 BLANKET
K952864 · DWJ
Augustine Medical, Inc.
Cardiovascular · 82d
Cleared Sep 12, 1995
EVOLUTION MICROCATHETER
K953114 · DQO
Boston Scientific Corp
Cardiovascular · 71d
Cleared Sep 07, 1995
HEARTCARD CARDIAC EVENT MONITOR
K944362 · DXH
Instromedix, Inc.
Cardiovascular · 365d
Cleared Sep 07, 1995
MARQUETTE DEFIB ELECTRODES
K952101 · MKJ
Marquette Electronics, Inc.
Cardiovascular · 126d
Cleared Sep 06, 1995
TROPICAIR CONVECTIVE WARING SYSTEM
K946196 · DWJ
Seabrook Medical Systems, Inc.
Cardiovascular · 260d
Cleared Sep 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM
K950476 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 215d
Cleared Sep 06, 1995
TROPICAIR CONVECTIVE WARMING BLANKETS
K952086 · DWJ
Seabrook Medical Systems, Inc.
Cardiovascular · 126d
Cleared Sep 01, 1995
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
K952364 · DXY
Ela Medical, Inc.
Cardiovascular · 123d
Cleared Aug 31, 1995
PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING
K951950 · DTB
Pacesetter, Inc.
Cardiovascular · 127d
Cleared Aug 31, 1995
PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING
K952206 · DTB
Pacesetter, Inc.
Cardiovascular · 113d