Atlas FDA

HAW

424 FDA 510(k) clearances · Product code

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MICROTABLE SYSTEM (K132611)Fred Haer Company, Inc.2014-03-06
CRANIAL MAP NEURO (K131214)Stryker Corporate2013-10-18
STRYKER NAV3I PLATFORM (K130874)Stryker Corporate2013-09-27
QUADCUT (K130608)Medtronic Navigation, Inc.2013-08-07
SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS (K122211)Synthes Spine2012-12-17
KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM (K122096)KARL STORZ Endoscopy-America, Inc.2012-09-27
MICROTARGETING XL STAR DRIVE SYSTEM (K121950)FHC, Inc.2012-07-26
RENAISSANCE (K120812)Mazor Robotics , Ltd.2012-07-12
PRAEZIS PLUS (K110644)Tatramed Spol. S.R.O.2012-05-24
BRAIN BIOPSY NEEDLE (K112094)Ad-Tech Medical Instrument Corp2012-04-24
SURGICASE GUIDE (K111558)Materialise NV2012-03-27
GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM (K112469)Sonowand AS2012-03-23
RENAISSANCE SYSTEM (K113228)Mazor Robotics , Ltd.2011-12-01
IPLAN (K101627)Brainlab AG2011-06-03
RENAISSANCE SYSTEM (K110911)Mazor Robotics , Ltd.2011-04-28
NAVIGATION MARKER, REFLECTIVE MARKER SPHERES (K103192)Ilumark GmbH2011-02-07
ROSA SURGICAL DEVICE (K101791)Medtech S.A.S2010-09-23
TENZING SYSTEM (K102130)Mazor Surgical Technologies , Ltd.2010-08-26
DISPOSABLE REFLECTIVE MARKER SPHERES (K100038)Brainlab AG2010-07-14
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED (K092467)Brainlab AG2010-05-06
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US (K100314)Medacta International S.A.2010-03-31
WAYPOINT STEREOTACTIC SYSTEM (K092192)FHC, Inc.2010-02-12
ROSA SURGICAL DEVICE, MODEL ROSA 1.1 (K092239)Medtech S.A2009-11-17
WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM (K090190)Nuclemed S.A.2009-10-09
SONOWAND INVITE (K083597)Sonowand AS2009-09-25
MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS (K092562)FHC, Inc.2009-09-18
MONTERIS MEDICAL UFO (K090240)Monteris Medical,2009-08-06
CRANIAL IMAGE GUIDED SURGERY SYSTEM (K082060)Brainlab AG2009-05-08
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS (K080355)Elekta Instrument AB2009-05-01
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 (K083565)Smith & Nephew, Inc.2009-02-20
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 (K081867)Mako Surgical Corp.2008-11-25
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 (K082267)Smith & Nephew, Inc.2008-10-29
BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED (K073615)Brainlab AG2008-09-05
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES (K081232)Praxim2008-08-06
PIGALILEO 4TH GENERATION SYSTEM (K080875)Smith & Nephew, Inc.2008-07-18
STRYKER POWER TOOL NAVIGATOR ATTACHMENT (K080450)Stryker Corp.2008-07-17
UNI-KNEE 2.0 (K080678)Brainlab AG2008-06-06
SPINEASSIST SYSTEM (K073467)Mazor Surgical Technologies , Ltd.2008-05-23
ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 (K080547)Aesculap Implant System, Inc.2008-05-23
LEKSELL SURGIPLAN, MODEL 1006947 (K080250)Elekta Instrument AB2008-05-13
ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 (K072899)Aesculap Implant Systems, Inc.2008-02-06
MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) (K072806)Mako Surgical Corp.2008-01-24
STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE (K072271)Stryker Corp.2007-12-18
TOTAL HIP SURGETICS NAVIGATION SYSTEM (K072267)Praxim S.A2007-12-10
VECTOR VISION HIP (K072716)Brainlab AG2007-10-12
VECTORVISION HIP AND HIP SR (K072573)Brainlab AG2007-10-11
BRAINSUITE NET (K070556)Brainlab AG2007-09-25
NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL (K071929)Orthosoft, Inc.2007-09-19
SPINEASSIST SYSTEM (K063607)Mazor Surgical Technologies , Ltd.2007-08-23
PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM (K070731)Plus Orthopedics AG2007-07-31
NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 (K071714)Orthosoft, Inc.2007-07-20
DEPUY CAS HEMI ASR HIP INSTRUMENTS (K071334)DePuy Orthopaedics, Inc.2007-07-02
DEPUY CI HIP INSTRUMENTATION (K071135)DePuy Orthopaedics, Inc.2007-05-23
VV FLUORO 3D (K070106)Brainlab AG2007-04-23
ARGOS (K061479)3D Line Medical Systems S.R.L.2007-04-05
CTLOGICS NAVIGATIONS SYSTEMS (K063408)Praxim Medivision, SA2007-02-28
MODIFICATION TO VECTORVISION TRAUMA (K062358)Brainlab AG2007-01-17
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 (K062640)Stryker Instruments2006-12-14
VECTORVISION HIP SR (K063028)Brainlab AG2006-12-12
ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION (K062228)Zimmer, Inc.2006-11-08
PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM (K061362)Plus Orthopedics AG2006-10-06
NAVIVISION (K062086)Brainlab AG2006-09-20
LAPDOC I (K061224)Robodent GmbH2006-09-05
AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM (K061248)Medtronic Navigation, Inc.2006-08-31
UNI KNEE SURGETICS NAVIGATION SYSTEM (K062146)Praxim S.A2006-08-21
VECTORVISION HIP (K060727)Brainlab AG2006-08-21
STRYKER ORTHOPAEDICS RFID INSTRUMENTATION (K053348)Howmedica Osteonics Corp.2006-08-04
BRIGIT SURGICAL DEVICE (K060556)Zimmer, Inc.2006-07-31
BRAINPRO, BRAINPRO ACCESS (K060808)PAJUNK GmbH Medizintechnologie2006-07-25
VECTORVISION SPINE (K053159)Brainlab AG2006-06-06
NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 (K060336)Orthosoft, Inc.2006-04-28
TOTAL KNEE SURGETICS NAVIGATION SYSTEM (K060282)Praxim S.A2006-04-10
SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM (K053542)Praxim S.A2006-04-10
IPLAN FLOW (K053164)Brainlab AG2006-03-23
BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS (K060121)Biomet Manufacturing Corp2006-03-21
VECTORVISION HIP (K060468)Brainlab AG2006-03-20
IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM (K052623)Medtronic Navigation, Inc.2006-03-02
CI KNEE, CI MI TKR (K052966)Brainlab AG2006-02-13
IPLAN (K053127)Brainlab AG2006-02-09
ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION (K052425)Zimmer, Inc.2005-12-28
IGI-SYSTEM (K052840)Denx Advanced Dental Systems2005-12-16
GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 (K051734)Ge Healthcare Technologies2005-11-23
VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) (K052851)Mako Surgical Corp.2005-11-18
NAVIGATION SW HIP 3.1 ON CI (K052213)Brainlab AG2005-11-02
DEPUY CAS HIP INSTRUMENTATION (K052178)DePuy Orthopaedics, Inc.2005-10-21
SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES (K051676)Mazor Surgical Technologies , Ltd.2005-09-08
MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION (K050651)Medtronic Navigation, Inc.2005-07-27
ELEKTA ESARTE FRAME SYSTEM (K051746)Elekta Instrument AB2005-07-25
ACUMEN IMAGE GUIDED SURGICAL SYSTEM (K051724)Ebi, L.P.2005-07-19
STELTHSTATION WIRELESS SURGEON MOUSE (K051029)Medtronic Surgical Navigation2005-06-08
SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM (K031196)Praxim2005-06-07
STEALTHSTATION SYSTEM UPDATE (K050438)Medtronic Surgical Navigation Technologies2005-06-02
MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 (K041897)Schaerer Mayfield USA, Inc.2005-06-01
NAVIPRO SHOULDER SOFTWARE MODULE (K050897)Kinamed, Inc.2005-05-24
IPLAN! DIGITAL TEMPLATING (K042543)Brainlab AG2005-05-17
MODIFICATION TO: VOYAGER LINUX (K050973)Mako Surgical Corp.2005-05-17
AESCULAP ORTHOPILOT 2 THA V 2.0 (K050752)Aesculap, Inc.2005-04-27
NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 (K050772)Image-Guided Neurologics, Inc.2005-04-21
STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000 (K050615)Stryker Instruments2005-04-21
KOLIBRI SPINE (K042721)Brainlab AG2005-04-19
← Previous Next →

Track HAW automatically

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