FDA 510(k) clearances — page 1608
clearances on record, most recent first.
Clearances — page 1608
160,701–160,800 of 175,890- K821465 — ULTRACHEM URIC ACID AIDH, #65047
- K821468 — ULTRAZYME PLUS-GT, #64959 & 65032
- K821469 — ULTRACHEM GLUC-DH, #65048
- K821470 — ULTRACHEM E-GLU #64976 & 65040
- K821471 — ULTRAZYME PLUS ALP #64962,65029&65030
- K821482 — STERILE HD PAN SET
- K821490 — SILKAFIX ADHESIVE PLASTER
- K821520 — MODEL 379 FLOW/DIVIDER
- K821547 — PACEMAKER UNIPOLAR ADAPTER
- K821548 — PACEMAKER CONNECTOR PLUG
- K821549 — PACEMAKER 445 ADAPTER
- K827507 — ENDOSCOPIC ACCESSORY U/S/ CLEANING MACHINE
- K820725 — SPAC T4 RIA TEST KIT
- K820854 — KENZ-45M
- K820857 — SAFE-T-SEAL
- K821005 — PLATELET AGGREGATION PROFILER #PAP-4
- K821241 — FREE T4 RADIOIMMUNOASSAY KIT
- K821266 — BBL DIRECTIGEN MENINGITIS TEST KIT
- K821301 — #50002 QUAD DIAGNOSTIC SYSTEM
- K821302 — #50003 QUAD DIAGNOSTIC SYSTEM
- K821375 — DEODORANT SURE & NATURAL MAXISHIELDS
- K821417 — TRYPTIC SOY AGAR W/10% SHEEP BLOOD
- K821418 — TRYPTOSE BLOOD AGAR W/5% SHEEP BLOOD
- K821419 — EMB AGAR
- K821420 — EMB AGAR
- K821421 — HEKTOEN ENTERIC AGAR
- K821422 — SS AGAR
- K821423 — MACCONKEY AGAR
- K821424 — TRYPTIC SOY AGAR W/5% SHEEP BLOOD
- K821425 — COLUMBIA BLOOD AGAR W/5% SHEEP BLOOD
- K821426 — STAPHYLOCOCCUS MEDIUM 1100
- K821427 — MANNITOL SALT AGAR
- K821428 — MUELLER HINTON CHOCOLATE MED. ENRICHED
- K821429 — MUELLER HINTON MED. W/5% SHEEP BLOOD
- K821430 — MUELLER HINTON MEDIUM
- K821431 — XLD AGAR
- K821439 — MR 600 MICROPLATE READER
- K821441 — ENZYMATIC CHOLESTERAL OXIDASE #650550
- K821457 — HEMACOUNT WRIGHTS STAIN PACK II #55952
- K821460 — ULTRAZYME PLUS CK-I, #64978,65027&65028
- K821462 — ULTRACHEM T-BILI, #64971
- K821466 — ULTRAZYME PLUS LDH, #64950,65038&65039
- K821467 — ULTRAZYME PLUS GOT, #64953,65033&65034
- K821493 — LITTMAN OXGAL AGAR
- K821561 — VERSACHEM ANALYZER
- K820564 — WORLD'S BEST (CONTRACEPTIVE)
- K820837 — DISPOSABLE MULTIPLE LIGATING CLIP
- K821012 — H-H ALIMENTATION CATHETERS
- K821014 — CORATOMIC MODEL OVALITH 920BP
- K821033 — CORATOMIC MODEL OVALITH-920
- K821144 — OHIO ABSORBER
- K821219 — SERIES 4 LIQUID CHROMATOGRAPH
- K821230 — SOFTIC 49
- K821238 — CC-700 SEVEN PARAMETER, AUTOMATED HEMAA
- K821248 — ROCHESTER PEAN FORCEPS
- K821273 — MAYO SCISSOR STRAIGHT 6 3/4
- K821275 — MAYO SCISSOR STRAIGHT 5 1/2
- K821276 — MAYO SCISSOR CURYED 5 1/2
- K821282 — THUMB DRESSING FORCEPS 5
- K821284 — ADSON FORCEPS 4 3/4
- K821285 — SPLINTER FORCEPS 4 1/2
- K821286 — IRIS SCISSORS STRAIGHT 4 1/2
- K821290 — LITTAUER SCISSORS 5 1/2
- K821292 — TONSIL SCISSORS 7
- K821293 — BACKHAUS CLAMP, 5 1/4
- K821294 — TONSIL SCISSORS STRAIGHT 5 1/2
- K821298 — BACKHAUS CLAMP, 3 1/2
- K821299 — CER-MATE
- K821312 — TEMPTREND TEMPERATURE TREND INDICATOR
- K821314 — FEVER METER
- K821317 — UNIVERSAL I.V. HOLDER
- K821326 — CUTTER BOND POLYCARBOXYLATE CEMENT
- K821337 — SHIGELLA I.D.
- K821338 — SALMONELLA I.D.
- K821344 — ENGSTROM METABOLIC COMPUTER
- K821346 — QUANTIMUNE HLH RIA
- K821347 — BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.
- K821358 — MODIFIED RONGEURS FOR SPINAL & ORTH. S.
- K821363 — TRANS-Q
- K821364 — PROFLEX FLEXIBLE SCALER
- K821367 — GF-180-M & GF-180-H HEMODIALYZERS
- K821374 — ENZYMUNE-TEST INSULIN
- K821379 — EMIT-TOX ACETAMINOPHEN ASSAY
- K821382 — CHEMISTRY CONTROL/STANDARD
- K821385 — SERO/TEX LE TEST
- K821399 — MACRO-VUE CARD TEST, NETILMICIN
- K821413 — EMIT C-REACTIVE PROTEIN ASSAY
- K821437 — DIGITAL BLOOD PRESSURE METER
- K821452 — DURAZYME CPK
- K821459 — ULTRAZYME PLUS AMYL #65031&64982
- K821488 — ELECATH PORTAL VEIN/BILIARY DRAIN ASSM
- K821516 — TRACKER-2 CHANNEL ECG TAPE RECORDER
- K821530 — SYRINGE IRRIGATING
- K821537 — HENKE DISPOSABLE SYRINGE
- K820002 — BARD CONTOUR LINK S.K.I. KNEE SYS
- K821038 — FAST VIOLET B
- K821160 — PNEUMO DRAIN T.M. RECORDER #PD-800
- K821187 — MEDCO CUSTOM EAR PROTECTOR MOLD KIT
- K821267 — THUMB DRESSING FORCEPS
- K821269 — TRACHEOSTOMY CARE TRAYS
Data sourced from openFDA. This site is unofficial and independent of the FDA.