510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Guilin Woodpecker Medical Instrument Co., Ltd

GUILIN CITY Guangxi, CN

GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD appears in FDA device records in GUILIN CITY Guangxi, CN. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
14
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 14 510(k) clearances for Guilin Woodpecker Medical Instrument Co., Ltd between 2006 and 2025. The busiest year on record is 2022, with 5. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Guilin Woodpecker Medical Instrument Co., Ltd, by decision year
YearClearances
20061
20081
20111
20181
20214
20225
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )EHDSubstantially Equivalent
K222569Ai Ray Dental X-Ray DeviceEHDSubstantially Equivalent
K211358Implanter incl. AccessoriesEBWSubstantially Equivalent
K221548Dental Air Polishing HandpieceEFBSubstantially Equivalent
K210367D-Laser Blue, D-Laser 16NVKSubstantially Equivalent
K203706Dental Electric MotorEBWSubstantially Equivalent
K211531Cordless Prophy System, Model: i-PolishEKXSubstantially Equivalent
K203615Dental Scaler and Air PolisherELCSubstantially Equivalent
K212080Imaging Plate Scanner, i-ScanMUHSubstantially Equivalent
K203320Endo MotorEKXSubstantially Equivalent
K181087Apex Locator, DPEX IIILQYSubstantially Equivalent
K111290PIEZO BONE SURGERYDZISubstantially Equivalent
K080025LED.L, LED.M, LED.G, LED.BEBZSubstantially Equivalent
K053555ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-LELCSubstantially Equivalent

Registered establishments

FDA registered establishments for Guilin Woodpecker Medical Instrument Co., Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30055810163005581016GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTDInformation Industrial Park, GUILIN CITY Guangxi 541004 CN2026and 15 more, listed in full below

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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