429 results · 12ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·September 28, 2016

G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·September 28, 2016

Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.

FDA Recall
Terminated ·C.R. Bard Access Systems, Inc·Product code MPB·August 10, 2007

Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants

FDA Recall
Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBE·August 26, 2016

G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBE·August 26, 2016

ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone including spine and cranium.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shaping bone including spine and cranium.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R. Orthopedic use.

FDA Enforcement
Class II ·Terminated·Wright Medical Technology, Inc.·April 29, 2015

CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2R. Orthopedic use.

FDA Enforcement
Class II ·Terminated·Wright Medical Technology, Inc.·April 29, 2015

CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use.

FDA Enforcement
Class II ·Terminated·Wright Medical Technology, Inc.·April 29, 2015

CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.

FDA Enforcement
Class II ·Terminated·Wright Medical Technology, Inc.·April 29, 2015

Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.

FDA Enforcement
Class II ·Terminated·Transonic Systems Inc·September 9, 2015

Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.

FDA Enforcement
Class II ·Terminated·Transonic Systems Inc·September 9, 2015

Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.

FDA Enforcement
Class II ·Terminated·Transonic Systems Inc·September 9, 2015

AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF Pl Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF PL Cages are to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

FDA Enforcement
Class II ·Terminated·Howmedica Osteonics Corp.·September 21, 2016

Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST

FDA Recall
Terminated ·Nextremity Solutions·Product code HWC·November 11, 2019

Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST

FDA Recall
Terminated ·Nextremity Solutions·Product code HWC·November 11, 2019

Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST

FDA Recall
Terminated ·Nextremity Solutions·Product code HWC·November 11, 2019

ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting shaping bone including spine and cranium.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015