FDA 510(k) clearances — page 1349
clearances on record, most recent first.
Clearances — page 1349
134,801–134,900 of 175,890- K882468 — ELIMINATOR AIR FILTER
- K882593 — MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM
- K882608 — LAD MODEL 633 LUMINOMETER
- K882676 — PHARMACIA CHLAMYDIA EIA
- K882726 — RAICHEM(TM) BILIRUBIN STANDARD
- K882795 — DADE(R) CK-MB IMMUNOASSAY CONTROL
- K882801 — RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.
- K882820 — MEDIPAC II EC (TM), MODEL 7900
- K882909 — SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN
- K882961 — EMIT QST CARBAMAZEPINE ASSAY
- K883115 — PMT SUBARACHNOID SCREW, MODEL NO.1350-2
- K883362 — L-15 MEDIUM, CATALOG NO. 200-2021
- K883363 — ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-2105
- K883364 — ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.210-3505
- K883365 — HORSE SERUM, ABATTOIR, NO. 110-1112
- K883366 — MEDIUM 199, CATALOG NO. 200-2031
- K883367 — CALF SERUM, CATALOG NO. 110-1125
- K883368 — NEWBORN CALF SERUM, CATALOG NO. 110-1130
- K883369 — L-15 MEDIUM, CATALOG NO. 210-4004
- K883370 — FISCHER'S MEDIUM CATALOG NO. 210-4007
- K883445 — HANKS' BALANCED SALTS (HBSS) 10X, NO. 210-3012
- K883446 — FETAL BOVINE SERUM, GAMMA IRRADIATED NO. 110-1122
- K883447 — MINIMUM ESSENTIAL MEDIUM EAGLE 10X, NO.210-3511
- K883448 — MINIMUM ESSENTIAL MEDIUM EAGLE NO. 200-2046
- K883449 — MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2048
- K883450 — SFRE 199-2 MEDIUM, CATALOG NO. 200-2192
- K883495 — MEDIUM 199, 10X, CATALOG NO. 210-3555
- K883496 — MINIMUM ESSENTIAL MEDIUM EAGLE (MEM), 210-3517
- K883497 — MEDIUM 199, 10X CATALOG NO. 210-3556
- K883498 — FETAL BOVINE SERUM, HEAT INACTIVATED NO.110-1123
- K883499 — MEDIUM 199, 10X, CATALOG NO. 210-3557
- K883500 — MCCOY'S 5A MEDIUM 10X NO. 210-3532
- K883501 — MCCOY'S 5A MEDIUM (CATALOG NO. 210-3531)
- K883502 — FETAL BOVINE SERUM, DEFINED NO. 110-1121
- K883514 — EXAKT CUTTING & GRINDING SYSTEM
- K881391 — ULTRASONIC DENTURE CLEANER
- K882000 — PRO-FECT O.R. TOWEL
- K882021 — PRO-FECT LAPAROTOMY SPONGES
- K882392 — BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES
- K882471 — ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA
- K882491 — CUTTING FLUID SYSTEM FOR DENTAL HIGH SPEED DRILLS
- K882696 — DERMICEL, MONTGOMERY STRAP
- K882772 — LQ1106 OPHTHALMIC YAG LASER
- K883024 — ORAL-B FLOSSERS
- K883250 — STERI-CLENS WOUND CARE KIT
- K883303 — MENTOR RAPID-SPAN (TM) TISSUE EXPANDER
- K883322 — DENTAL HAND INSTRUMENTS
- K883335 — COLGATE DENTAL FLOSS
- K883420 — LANCET, BLOOD
- K883457 — ASST-3000 SPINAL SURGERY TABLE
- K883464 — SURGICAL SHIRT
- K873529 — HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT
- K874854 — GPS/WGPS/PREVIEW GP
- K880314 — HYSTEROSCOPE AUTONOM 4992
- K880511 — XACT NEISSERIA
- K882238 — VESSEL DILATOR AND INTRODUCER SHEATH
- K882273 — HORIZON 2000 PULSE OXIMETRY AND MODULE
- K882325 — UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
- K882361 — STIHLER ASTOTHERM IFT 200, IFT 220
- K882367 — METATECH MICROCLIP APPLICATOR
- K882370 — SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER
- K882444 — COAG-I ANALYZER, ALPHA MODEL
- K882452 — MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD
- K882456 — COAG-I PT TEST CARD
- K882503 — 30 IV EXTENSION SET W/TWO MALE LUER LOCKS
- K883100 — MULTIPLE SPECTACLE FRAMES
- K883208 — HISTO-CHECK SLIDES
- K883333 — RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT
- K883473 — SURGICAL CONNECTING TUBES
- K883484 — OWREN'S VERONAL BUFFER
- K880769 — BREATHING CIRCUIT W/HEATED WIRE
- K881270 — GAMBRO MULTIPURPOSE SYSTEM MPS-10
- K881767 — VIGGO INSUFLON
- K881834 — MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
- K882159 — 522 INTELLIGENT PUMP
- K882661 — ACUMED 9000 ETCO(2) MONITOR
- K882743 — OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
- K882769 — SUNGLASSES, NON-PRESCRIPTION
- K883114 — SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1
- K883226 — OPTICAL OR EYEGLASS FRAME
- K883238 — GENESIS II TRANSCRANIAL PROBE
- K883480 — MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE
- K873121 — GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS)
- K875049 — MD STRIPS BG
- K881775 — BD MICROFINE IV PEN INJECTOR
- K881826 — ENDO-ICE
- K882114 — AMISCO U-100 INSULIN SYRINGE
- K882766 — EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
- K882942 — LASER MIXTURE
- K883064 — MASSAGE MACHINE (CAT. EM-01 ULE 111756)
- K883244 — PRISTINE XTRA, SURGEON'S GLOVE
- K883295 — CHOP SPINE FRAME
- K883299 — SUTURE RETENTION DEVICE
- K883336 — GASTROSTOMY FEEDING TUBE
- K883338 — SURGICAL SEALANT APPLICATOR
- K883351 — PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBE
- K883357 — MODEL 1080 ROLLER MASSAGE TABLE
- K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE
- K872786 — SUNGLASSES
- K881517 — B & B I/A HANDPIECE
Data sourced from openFDA. This site is unofficial and independent of the FDA.