Datascope Corp.
Datascope Corp. holds FDA 510(k) medical device clearances, first cleared 1976, most recent 2019, with 67 FDA device recalls on record.
Clearances by Datascope Corp. — page 2
101–136 of 136- K850482 — DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
- K851904 — DATA TRAC ANESTHESIOLOGY RECORDER
- K844353 — PHYSIOLOGICAL MONITOR 2100
- K842538 — ACCUTORR CSM SYSTEM
- K831235 — IABP #90 SYSTEM
- K833828 — PERCOR 9.5 FR IAB ON DATASCOPE CO2
- K844447 — M/D4 W/CHARGER (CARDIOPAC 3M11)
- K841878 — SHEATH REMOVER
- K831307 — PECOR 8.5 FRENCH IAB ON A DATASCOPE
- K831397 — FRENCH INTRA-AORTIC 9.5 BALLOON ON KON
- K831776 — CAPNOGRAPH
- K832386 — PERCLUDER DL OCCLUDING BALLOON
- K823342 — PERCOR INTRA-AORTIC BALLOON INSERTION
- K821951 — DATASCOPE MODEL 83 IABP SYSTEM
- K820882 — PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC
- K821065 — DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL
- K820834 — PERCOR PERCUTANEOUS INTRODUCER
- K813182 — DATASCOPE MODIFIED #82 IABP SYSTEM
- K812828 — MODEL 2000 MONITOR
- K812259 — NIVP MONITOR
- K812271 — CENTRAL STATION MONITOR
- K811372 — MODEL 84 TRANSPORT SYSTEM
- K811638 — DATASCOPE INTERNAL DEFIBRILLATOR PADDLES
- K810297 — DATASCOPE PERCOR=DL DUAL-LUMEN INTRA
- K801601 — DATASCOPE/AVCO CONNECTOR
- K802167 — PERCOR DATASCOPE INTRA-AORTIC BALLOON
- K790775 — INTRA-AORTIC BALLOON, TYPE S
- K781163 — ELECTRODE, DEIP.
- K780280 — BALLOON PUMP
- K780043 — ESIS MODULE
- K772052 — PHYSIOLOGICAL RECORDER MODEL 721A
- K772054 — PHYSIOLOGICAL RECORDER MODEL 740
- K772056 — PHYSIOLOGICAL MONITOR MODEL 871
- K772053 — LINE CHARGER MODEL LC-100
- K761017 — PRESSURE MODULE (MODEL P3)
- K760803 — PHYSIOLOGICAL MONITOR (MODEL 870)
Data sourced from openFDA. This site is unofficial and independent of the FDA.