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Rongeur, Manual

Regulation 882.4840

1510(k)s in 12 months (37 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
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Top companies in HAE

Company510(k)sRecalls
Baxano, Inc.60
Morpheus AG30
Folsom Metal Products, Inc.02
Integra Lifesciences Corp.20
Symmetry Surgical20
Von Zeppelin GmbH20
Ace Medical10
Aesculap, Inc.10
Dannoritzer Medical Instruments10
Enterprise Medical Corp.10
Decided510(k)Device and applicantCode
Sep 15, 2026K260446Tontarra Punches and Rongeurs
Tontarra Medizintechnik GmbH, DE
HAE
Jun 6, 2025K242759Geister K-Rex rongeurs
Geister Medizin Technik GmbH, DE
HAE
Jun 29, 2023K223596SQ.line KERRISON
Aesculap, Inc.
HAE
Mar 3, 2023K230256Rebellion, Phantom Multi-Bite Kerrison Rongeur
Morpheus AG, DE
HAE
Oct 7, 2022K221818Rebellion; Phantom Multi-Bite Kerrison Rongeur
Morpheus AG, DE
HAE
Jun 3, 2022K210741KLS Martin Neuro Rongeurs
KLS-Martin L.P.
HAE
May 4, 2021K200768Rebellion, Phantom Multi-Bite Kerrison Rongeur
Morpheus AG, DE
HAE
Jul 21, 2020K200387Ace Medical Surgical Instruments
Ace Medical
HAE
Jul 21, 2020K200383Wiggins Medical Surgical Instruments
Wiggins Medical
HAE
Nov 8, 2018K180949Steribite
Rjr Surgical, Inc.
HAE
Sep 7, 2016K161744Symmetry Sharp Kerrison Rongeur
Symmetry Surgical, Inc.
HAE
Aug 4, 2016K153243Fehling-Punches
Fehling Instruments GmbH & Co. KG, DE
HAE
Jun 18, 2016K152734Kerrison Rongeurs
Vitalitec Medizintechnik GmbH, DE
HAE
Feb 29, 2016K150468Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
K2 Medical GmbH & Co. KG, DE
HAE
Apr 16, 2015K150428Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R)
Integra Lifesciences Corp.
HAE
Dec 6, 2013K131851OSTEOMED NEURO RONGEUR
Osteomed
HAE
Aug 5, 2013K130541SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
Symmetry Surgical
HAE
Jul 27, 2012K113073IO-TOME DEVICE
Baxano, Inc.
HAE
Apr 11, 2012K113533NEURO CHECK DEVICE WITH IO-FLEX WIRE
Baxano, Inc.
HAE
Jul 23, 2010K100958MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES
Baxano, Inc.
HAE
Feb 17, 2010K092227JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
Integra Lifesciences Corp.
HAE
Aug 8, 2008K081651INSTRUMED RONGEUR
Instrumed International, Inc.
HAE
Mar 4, 2008K080494BAXANO ULTRA LOW PROFILE RONGEUR
Baxano, Inc.
HAE
Apr 16, 2007K063231MICROBLADE SHAVER AND ACCESSORIES
Baxano, Inc.
HAE
Mar 7, 2007K062711ULTRA LOW PROFILE RONGEUR
Baxano, Inc.
HAE
Feb 7, 2003K023868DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
Dannoritzer Medical Instruments
HAE
Dec 6, 1995K954699BRAY RONGEUR
Johnson & Johnson Professionals, Inc.
HAE
Feb 21, 1995K943583KERRISON RONGEURS
Enterprise Medical Corp.
HAE
Dec 7, 1994K943635ULTRA-LINE RONGEUR
V. Mueller Neuro/Spine
HAE
Jul 27, 1994K943116AUTO SUTURE KERRISON SPINAL RONGEUR
United States Surgical, A Division of Tyco Healthc
HAE
Jan 12, 1994K933978NEDBOND EJECTOR KERRISON RONGEUR
Redmond Neurotechnologies Corp.
HAE
Dec 11, 1990K903151INTERVERTEBRAL DISC RONGEUR
Von Zeppelin GmbH, DE
HAE
Aug 10, 1990K903401SPECIAL RONGEUR
Sur-Med Instruments, Inc.
HAE
Jul 23, 1990K901313INSTRUMENTS FOR NEUROLOGICAL SURGERY
Von Zeppelin GmbH, DE
HAE
Jun 28, 1990K901372LAMINECTOMY RONGEUR
Zeppelin GmbH, DE
HAE
May 11, 1989K892535NEUROLOGICAL RONGEURS - VARIOUS TYPES
Zinnanti Surgical Instruments, Inc.
HAE
Jan 22, 1988K875043RONGEUR (NEUROSURGICAL INSTRUMENTS)
Solway, Inc.
HAE

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