Medical Device Manufacturer · US , Burlingame , CA

Aesculap, Inc. - FDA 510(k) Cleared Devices

207 submissions · 201 cleared · Since 1991
207
Total
201
Cleared
0
Denied
207 devices
101-125 of 207
Cleared Jul 25, 2003
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K032059 · KWQ
Orthopedic · 23d
Cleared Jun 04, 2003
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303 · JXG
Neurology · 41d
Cleared May 29, 2003
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K031286 · GAM
General & Plastic Surgery · 36d
Cleared Apr 22, 2003
STEELEX ELECTRODE SET
K030556 · LDF
Cardiovascular · 60d
Cleared Mar 24, 2003
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
K024349 · HCH
Neurology · 84d
Cleared Mar 20, 2003
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
K030698 · JXG
Neurology · 14d
Cleared Dec 19, 2002
STEELEX STERNUM SET
K023411 · GAQ
General & Plastic Surgery · 69d
Cleared Dec 13, 2002
COLUMBUS (CR) TOTAL KNEE SYSTEM
K023788 · JWH
Orthopedic · 30d
Cleared Nov 08, 2002
COLUMBUS TOTAL KNEE SYSTEM (CR)
K022672 · JWH
Orthopedic · 88d
Cleared Oct 21, 2002
CRANIOCUT
K022942 · HBE
Neurology · 46d
Cleared Jul 25, 2002
ORTHOPILOT HTO MODULE
K021327 · HAW
Neurology · 90d
Cleared Jul 22, 2002
SEARCH EVOLUTION TOTAL KNEE SYSTEM
K021313 · JWH
Orthopedic · 88d
Cleared Apr 05, 2002
MIETHKE SHUNT SYSTEM
K020728 · HCA
Neurology · 30d
Cleared Apr 04, 2002
ORTHOPILOT 2
K013569 · HAW
Neurology · 157d
Cleared Mar 21, 2002
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083
K014207 · GEI
General & Plastic Surgery · 90d
Cleared Mar 19, 2002
NELSON ELECTROSURGICAL UNIT, MODEL GN640
K014172 · GEI
General & Plastic Surgery · 89d
Cleared Mar 18, 2002
PAEDISCOPE, MODEL # P010A AND PF011A
K014149 · GWG
Neurology · 90d
Cleared Mar 01, 2002
AESCULAP -MIETHKE SHUNT SYSTEM
K011030 · JXG
Neurology · 330d
Cleared Nov 16, 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · KWQ
Orthopedic · 179d
Cleared Oct 03, 2001
BIPOLAR IRRIGATION FORCEPS
K012986 · GEI
General & Plastic Surgery · 27d
Cleared Sep 19, 2001
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
K012201 · GAT
General & Plastic Surgery · 68d
Cleared Aug 03, 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102 · HWC
Orthopedic · 114d
Cleared Aug 01, 2001
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011372 · GAM
General & Plastic Surgery · 89d
Cleared Jul 31, 2001
SCALPFIX CLIP SYSTEM
K012219 · HBO
General & Plastic Surgery · 15d
Cleared Jun 29, 2001
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011375 · GAM
General & Plastic Surgery · 56d

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