Atlas FDA

HFW

36 FDA 510(k) clearances · Product code

81 daysmedian time to decision
286 days90th percentile
36clearances measured

FDA profile

Official device name
Clamp, Umbilical
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Medical specialty
Obstetrics/Gynecology
Adverse events (MAUDE)
2001: 2 · 2002: 1 · 2003: 1 · 2004: 2 · 2008: 3 · 2009: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
JOEY CLAMP OPENING TOOL (K041332)Maternus, Inc.2004-06-25
KAEN YIH UMBILICAL CORD CLAMP (K033846)Kaen Yih Enterprise Co., Ltd.2004-03-11
SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE (K020718)Precision Dynamics Corp.2002-06-03
BUSSE UMBILICAL CORD CLAMP CUTTER (K021055)Busse Hospital Disposables, Inc.2002-04-29
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B (K012917)Dynarex Corp.2001-11-28
KOALA CLAMP, KOALA CLAMP AND CUTTER (K011621)Maternus, Inc.2001-08-10
KOALA CLAMP (K010695)Maternus, Inc.2001-05-03
POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 (K010835)Busse Hospital Disposables, Inc.2001-04-30
UMBICUT (K000227)Pollak (Intl.), Ltd.2000-04-27
UMBILICAL CORD CLAMP (K994367)Medical Sales Co.2000-03-17
SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 (K994263)Precision Dynamics Corp.2000-01-24
'ECURLINE UMBILICAL CORD CLAMP #3500 (K990737)Precision Dynamics Corp.1999-04-06
HARWILL MEDICAL U-KLIP UMBILICAL CLAMP (K983204)Harwill Medical (Pty) , Ltd.1999-02-26
HOSPITAL'S CLAMP (K974227)Gps1997-12-12
EZ-CIRC (K963223)Phyllis Adams, Rn, Npc, Msn1997-04-23
QFC UMBILICAL CLAMP (K963889)Qfc Industries1997-04-18
UMBILICAL CLAMP AND CUTTER (K963428)R.O.S.T. Medical Development, Inc.1997-04-01
BIRTH THEFT INFANT IDENTIFICATION AND PROTECTION UMBILICAL CORD CLAMP (K945841)W G M Corp.1995-05-30
KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR (K951140)Balagan Medical, Inc.1995-05-25
SAVE-T-BREATH AMBILICAL CORD CLAMP (K933763)Save-T-Breath Distributors C.C.1994-08-29
AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER (K934525)United States Surgical, A Division of Tyco Healthc1994-02-14
LUNEAU UMBILICAL CORD CLAMP (K923439)Laboratoires Luneau1993-05-21
CORDGUARD BLOOD COLLECTION DEVICE (K912419)O.B. Tech., Inc.1992-10-05
UMBILICAL CLAMP (K915569)Gam Industries, Inc.1992-09-23
LABOR DELIVERY TRAY (K912054)Medical Device Inspection Co., Inc.1992-01-21
WOMEN AND INFANT'S DELIVERY PACK (K912869)Welcon, Inc.1991-12-04
AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC (K901954)Hollister, Inc.1990-07-26
UMBILICAL CORD CLAMP AND CUTTER (K901557)Microtek-Heritage, Inc.1990-05-15
#556 DISPOSABLE UMBILICAL CORD CLAMP (2) (K894646)Alpha Unlimited, Inc.1989-09-05
COMPRESSION FORCEPS (K890382)Kinetic Medical Products1989-02-27
UMBILICAL CORD CLAMP (K880753)I M, Inc.1988-04-27
SCMT UMBILICAL CLAMP (K871075)Salt Creek Medical Technologies1987-03-23
DOLPHIN UMBILICAL CORD CLAMP (K870446)Andermac, Inc.1987-02-17
SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000 (K863645)United Medical Systems, Inc.1986-09-25
CLAMP-N-CUT (K860445)Mmi, Inc.1986-04-04
UMBILICAL CORD CLAMP (K781548)Hollister, Inc.1978-10-17

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