Imm Enterprises, Ltd.
Walker, MI, US
Imm Enterprises , Ltd. appears in FDA device records in Walker, MI. FDA records list 52 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 52
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 52FDA records hold 52 510(k) clearances for Imm Enterprises, Ltd. between 1983 and 1984. The busiest year on record is 1984, with 49. The most recent is 1984, with 49.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 3 |
| 1984 | 49 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K841387 | WESTON RECTAL SNARE | KOA | Substantially Equivalent | |
| K841386 | KOLLMANN URETHRAL DILATOR | KOE | Substantially Equivalent | |
| K840311 | CAT. 7-EAR, NOSE & THROAT DEVICES | KCP | Substantially Equivalent | |
| K840304 | CATEGORY 17-MICROBIOLOGY DEVICES | HTD | Substantially Equivalent | |
| K840318 | CAT. 14-CLINICAL TOXIOLOGY DEVICES | HTD | Substantially Equivalent | |
| K840305 | CATEGORY 1 CIRCULATORY SYSTEM DEVICE | DWS | Substantially Equivalent | |
| K840312 | CAT. 8 DENTAL DEVICES | EMG | Substantially Equivalent | |
| K834171 | OP-CON SURG. INSTRUMENT #3 | KOA | Substantially Equivalent | |
| K834192 | JAKOBI SURG. INSTRUMENTS #3 21/22/24 | KOA | Substantially Equivalent | |
| K834191 | JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 | KOA | Substantially Equivalent | |
| K840310 | CATEGORY 6 OPTHALMIC DEVICES | HOB | Substantially Equivalent | |
| K840320 | CAT. 16-IMMUNOLOGY DEVICES | HTD | Substantially Equivalent | |
| K840319 | CAT 15-HEMATOLOGY & PATHOLOGY DEVICE | HTD | Substantially Equivalent | |
| K840317 | CAT 13-CLINICAL CHEMISTRY DEVICES | HTD | Substantially Equivalent | |
| K840316 | CAT 12-ORTHOPEDIC & REHAB DEVICE | HTD | Substantially Equivalent | |
| K840315 | CAT 11- GENERAL & PLASTIC SURGERY DEV | HTD | Substantially Equivalent | |
| K840309 | CAT. 5-RADIOLOGY DEVICES | HTD | Substantially Equivalent | |
| K840307 | CAT. 3 GASTROENTEROLOGY-UROLOGY DEV | HTD | Substantially Equivalent | |
| K840306 | CATEGORY 2 GEN. HOSPITAL & PERSONAL USE | HTD | Substantially Equivalent | |
| K834540 | OP-CON SURGICAL INSTRUMENT #9 | KBN | Substantially Equivalent | |
| K834190 | JAKOBI SURG. INSTRUMENTS #8 15 | EMH | Substantially Equivalent | |
| K834189 | JAKOBI SURG. INSTRUMENTS #7 44/47 | EPY | Substantially Equivalent | |
| K834188 | JAKOBI SURG. INSTRUMENTS #7 10/43 | JYL | Substantially Equivalent | |
| K834172 | OP-CON SURG. INSTRUMENT #7 | EQN | Substantially Equivalent | |
| K840308 | CAT. 4-OBSTETRICS GYNECOLOGY DEV'S | KOH | Substantially Equivalent | |
| K834187 | JAKOBI SURG. INSTRUMENTS #6 50 | HKY | Substantially Equivalent | |
| K840314 | CAT 10-NEUROLOGY DEVICE | GWZ | Substantially Equivalent | |
| K834178 | H.R. JAKOBI SURG. INSTR. #10 34/36 | GWZ | Substantially Equivalent | |
| K834170 | OP-CON SURG. INSTRUMENT #10 | GWZ | Substantially Equivalent | |
| K834193 | JAKOBI SURG. INSTRUMENTS #2 70/71 | FRG | Substantially Equivalent | |
| K840313 | CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV | BWB | Substantially Equivalent | |
| K834542 | H.R. JAKOBI SURG. INSTRU. SECT. 48 | HTD | Substantially Equivalent | |
| K834541 | H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 | GDX | Substantially Equivalent | |
| K834198 | JAKOBI SURG. INSTRUMENTS #12 40/41 | FZO | Substantially Equivalent | |
| K834197 | JAKOBI SURG. INSTR- #11 38/39/45/46/67 | EMF | Substantially Equivalent | |
| K834196 | JAKOBI SURG. INSTRUMENTS #11 20/25/27/37 | GAD | Substantially Equivalent | |
| K834195 | JAKOBI SURG. INSTRUMENTS #11 11/13/14 | GES | Substantially Equivalent | |
| K834194 | JAKOBI SURG. INSTRUMENTS #1 19/10/26 | GES | Substantially Equivalent | |
| K834186 | JAKOBI SURG. INSTRUMENTS #11 | Substantially Equivalent | ||
| K834185 | JAKOBI SURG. INSTRUMENTS #11 14/45 | HTD | Substantially Equivalent | |
| K834184 | H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 | EMF | Substantially Equivalent | |
| K834183 | H.R. JAKOBI SURG. INSTRUMENTS #11 25/39 | HTD | Substantially Equivalent | |
| K834182 | H.R. JAKOBI SURG. INSTRUMENTS #11 27/37 | GES | Substantially Equivalent | |
| K834181 | H.R. JAKOBI SURG. INSTRUMENTS #11 16/46 | GAD | Substantially Equivalent | |
| K834180 | H.R. JAKOBI SURG. INSTRUMENTS #11 13/20 | HTD | Substantially Equivalent | |
| K834179 | H.R. JAKOBI SURG. INSTRUMENTS #9 48 | BTO | Substantially Equivalent | |
| K834176 | H.R. JAKOBI SURG. INSTRUMENTS 40/41 | GEG | Substantially Equivalent | |
| K834175 | OP-CON SURG. INSTRUMENTS #11 | HRQ | Substantially Equivalent | |
| K834169 | OP-CON SURGICAL INSTRUMENT #9 | BWB | Substantially Equivalent | |
| K834177 | H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 | HGE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HGEAmniotome
- GESBlade, Scalpel
- FZOChisel, Surgical, Manual
- HOBClamp, Muscle, Ophthalmic
- KOEDilator, Urethral
- GEGElevator, Surgical, General & Plastic Surgery
- HTDForceps
- EMHForceps, Rongeur, Surgical
- HCZForceps, Surgical, Gynecological
- EMGForceps, Tooth Extractor, Surgical
- BWBForceps, Tube Introduction
- KBNGag, Mouth
- HRQHemostat
- JYLHook, Microsurgical Ear
- KOHInstrument, Manual, General Obstetric-Gynecologic
- DWSInstruments, Surgical, Cardiovascular
- EMFKnife, Surgical
- EQNLaryngoscope, Nasopharyngoscope
- LBXPelvimeter, Internal
- GWZPercussor
- GADRetractor
- GDXScalpel, One-Piece
- EPYSpeculum, Ent
- KOASurgical Instruments, G-U, Manual (And Accessories)
- KCPSyringe, Ent
- HKYTonometer, Manual
- BTOTube, Tracheostomy (W/Wo Connector)
- FRGWrap, Sterilization
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