510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Heidelberg Engineering GmbH

Franklin, MA, US

HEIDELBERG ENGINEERING GMBH appears in FDA device records in Franklin, MA. FDA records list 26 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
26
PMA records
0
Recall records
2
Registered establishments
2

FDA records under these names

1 name

FDA records resolved to Heidelberg Engineering GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • HEIDELBERG ENGINEERING U.S. Coprorate Officeregistration

510(k) clearance history

FDA records hold 26 510(k) clearances for Heidelberg Engineering GmbH between 1991 and 2026. The busiest year on record is 1994, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Heidelberg Engineering GmbH, by decision year
YearClearances
19911
19943
19971
20041
20062
20101
20111
20121
20161
20171
20183
20191
20201
20211
20232
20243
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleOBOSubstantially Equivalent
K250868SPECTRALIS HRA+OCT and variantsOBOSubstantially Equivalent
K240924AnterionOBOSubstantially Equivalent
K241163SPECTRALIS with Flex ModuleOBOSubstantially Equivalent
K240221SPECTRALIS HRA+OCT and variantsOBOSubstantially Equivalent
K223557SPECTRALIS HRA+OCT and variantsOBOSubstantially Equivalent
K230897AnterionOBOSubstantially Equivalent
K211817AnterionOBOSubstantially Equivalent
K201252Spectralis HRA+OCT and variantsOBOSubstantially Equivalent
K192391Spectralis HRA+OCT and VariantsOBOSubstantially Equivalent
K182569Spectralis HRA+OCT and variants with High Magnification ModuleOBOSubstantially Equivalent
K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleOBOSubstantially Equivalent
K173648Spectralis HRA + OCT and variantsOBOSubstantially Equivalent
K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with MulticolorOBOSubstantially Equivalent
K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith MulticolorOBOSubstantially Equivalent
K121993SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCTOBOSubstantially Equivalent
K113129SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)OBOSubstantially Equivalent
K101223SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FAOBOSubstantially Equivalent
K063191HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCTOBOSubstantially Equivalent
K052935HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)MXKSubstantially Equivalent
K042742HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)MXKSubstantially Equivalent
K971671HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)HLISubstantially Equivalent
K944261RETINA ANGIOGRAPHHLISubstantially Equivalent
K943956RETINA TOMOGRAPH AND FLOWMETERHLISubstantially Equivalent
K943955RETINA FLOWMETERHLISubstantially Equivalent
K912891HEIDELBERG RETINA TOMOGRAPHHLISubstantially Equivalent

Registered establishments

FDA registered establishments for Heidelberg Engineering GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
80437623002807157HEIDELBERG ENGINEERING GMBHMax-Jarecki-Str. 8, HEIDELBERG Baden-Wurttemberg 69115 DE2026
20858383000204964HEIDELBERG ENGINEERING U.S. Coprorate Office10 Forge Pkwy, Franklin, MA 02038 US2026No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2437-2019SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.Error in the default configuration which could lead to the incorrect display of patient master data.Class IITerminated
Z-1535-2018Widefield OCT software feature for the Spectralis HRA+OCT and variantsFDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked Heidelberg Engineering to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained for this software feature.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain