Atlas FDA

HHI

24 FDA 510(k) clearances · Product code

61 daysmedian time to decision
107 days90th percentile
24clearances measured

FDA profile

Official device name
System, Abortion, Vacuum
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5070
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
1993: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Berkeley VC-10 Vacuum Curettage System (K171440)Gyrus Acmi2017-09-29
BERKELEY V-10 VACUUM CURETTAGE SYSTEM (K030935)Acmi Corporation2003-06-23
CYTOPREP (K983181)Cytoprep Inc. Est.1998-11-16
MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER (K931205)Baxter Healthcare Corp1994-03-15
CYTOSMEAR BRUSH (K904160)Brooke Intl.1990-11-02
CANNULA, SUCTION UTERINE (K900641)Williams Specialty Products, Inc.1990-03-30
SWIVEL ADAPTER (K900642)Williams Specialty Products, Inc.1990-03-19
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (K880734)Personal Products Co.1988-04-25
CANNULA AND GENERAL PURPOSE ASPIRATOR (K873552)Cosmedtech, Inc.1987-11-25
COSMEDTECH GENERAL ASPIRATOR (K870574)Cosmedtech, Inc.1987-03-05
COSMEDTECH CANNULA (K870560)Cosmedtech, Inc.1987-03-04
LS3000 CANNULA UTERINE SUCTION (K862476)Engineering, Inc.1986-07-18
GYNASPYR VACUUM CURETTAGE UNIT (K850312)Roseburg SA1985-02-28
MODEL 3014 SUCTION UNIT (K841631)Forma Scientific, Inc.1984-07-03
VACUUM ASPIRATION CATHETER (K840382)Intl. Medical Technologies, Inc.1984-04-30
MENSTRUAL ASPIRATION KIT (K840383)Intl. Medical Technologies, Inc.1984-04-30
TAPERED CERVICAL DILATOR (K840381)Intl. Medical Technologies, Inc.1984-04-30
DIAGNOSTIC DILATATION & MENSTRUAL KIT (K840384)Intl. Medical Technologies, Inc.1984-04-30
MEDEVICE V-80 VACUUM PUMP (K840952)Berkeley Medevices1984-03-30
EPCOM VCU-1 VACUUM SYSTEM & CURETTE (K831112)Epcom Medical Systems, Inc.1983-06-30
SYNEVAC VACUUM CURETTAGE SYSTEMS (K813282)Synemed, Inc.1981-12-14
UTERINE VACUM ASPIRATING CURRETTE (K802360)American Hospital Supply Corp.1980-10-31
VABRA ASPIRATOR (K800833)Cooper Medical Devices Corp.1980-05-14
VABRA ABORTION UNIT (K780387)Cooper Laboratories1978-04-12

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Every clearance here is in the API, with alerts when new ones post.