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
11137–11160 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 14, 1994
BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER
K936232 · DSP
Boston Scientific Corp
Cardiovascular · 289d
Cleared Oct 14, 1994
ARTERIAL EMBOLIZATION DEVICE (KRD)
K940982 · KRD
Cook, Inc.
Cardiovascular · 227d
Cleared Oct 13, 1994
SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER
K943777 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 72d
Cleared Oct 13, 1994
7 FRENCH LARGE LUMEN TRIGUIDE-PLUS
K943783 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Oct 04, 1994
ULTATHIN FLEXIBLE ENDOSCOPE
K941715 · LYK
Technology Marketing Group
Cardiovascular · 180d
Cleared Sep 28, 1994
LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI
K933014 · KFM
St. Jude Medical, Inc.
Cardiovascular · 464d
Cleared Sep 27, 1994
MODEL 4800 ACCUPACE PACING SYSTEM ANALYER
K925143 · DTE
Pace Medical
Cardiovascular · 714d
Cleared Sep 26, 1994
EPCOR
K930786 · DRW
Siemens Medical Solutions USA, Inc.
Cardiovascular · 587d
Cleared Sep 22, 1994
CARDIAC CATHETERIZATION KIT
K932141 · DQO
Abbott Laboratories
Cardiovascular · 518d
Cleared Sep 21, 1994
TAYLOR LONG TERM MONITORING ELECTRODE
K941977 · DRX
Taylor Industries, Inc.
Cardiovascular · 155d
Cleared Sep 21, 1994
URESIL DILATOR
K942191 · DYB
Uresil Corp.
Cardiovascular · 140d
Cleared Sep 21, 1994
LIONHEART 3 MULTI-PARAMETER SIMULATOR
K944257 · DRT
Bio-Tek Instruments, Inc.
Cardiovascular · 21d
Cleared Sep 19, 1994
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE
K943022 · DQX
Cardio Metrics, Inc.
Cardiovascular · 87d
Cleared Sep 19, 1994
WARMTOUCH PLASTIC WARMING COVER
K943276 · DWJ
Mallinckrodt Medical
Cardiovascular · 74d
Cleared Sep 16, 1994
CORDIS STEERABLE GUIDEWIRE
K943340 · DQX
Cordis Corp.
Cardiovascular · 66d
Cleared Sep 14, 1994
VIP PLUS PERCUTANEOUS INTRODUCER
K944107 · DYB
Medamicus, Inc.
Cardiovascular · 22d
Cleared Sep 13, 1994
INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION
K940231 · DSP
Datascope Corp.
Cardiovascular · 238d
Cleared Sep 08, 1994
MS CLASSIQUE BALLOON CATHETER
K943298 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 62d
Cleared Sep 07, 1994
UNIPOWER RECHARGEABLE BATTERY PACK
K940842 · LDD
Unipower Corp.
Cardiovascular · 196d
Cleared Sep 06, 1994
ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES
K935281 · DRX
Arbo Medical, Inc.
Cardiovascular · 307d
Cleared Sep 06, 1994
ELECTRONIC-AMPLIFIED STETHOSCOPE
K941763 · DQD
Hsues' Brothers Medical, Inc.
Cardiovascular · 148d
Cleared Sep 06, 1994
TECHNICUFF
K942259 · DXQ
Technicuff Corp.
Cardiovascular · 120d
Cleared Sep 01, 1994
PROPAQ ECG TELEMETRY OPTION
K934711 · DRG
Protocol Systems, Inc.
Cardiovascular · 335d
Cleared Sep 01, 1994
SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIES
K941710 · DQX
Scimed Peripheral Interventions
Cardiovascular · 148d