FDA 510(k) clearances — page 748
clearances on record, most recent first.
Clearances — page 748
74,701–74,800 of 176,637- K023041 — W.O.M. LASER U100
- K023188 — PRESS-FIT HEAD RESURFACING DEVICE
- K023232 — SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
- K023267 — T2 SUPRACONDYLAR NAIL SYSTEM
- K023299 — ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
- K023330 — BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
- K023379 — COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER
- K023395 — PORTADUR P2
- K023597 — ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
- K023777 — ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183
- K023803 — MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
- K023880 — CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
- K023923 — SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE
- K023928 — MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL
- K023932 — GE PHOTON ENERGY RECOVERY (PER) OPTION
- K014296 — CD HORIZON SPINAL SYSTEM
- K020085 — SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
- K022133 — BD DIRECTIGEN EZ RSV KIT
- K022284 — SNORE-AID MAX
- K022377 — THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306
- K023019 — VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
- K023077 — OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)
- K023161 — SMARTSTEP SYSTEM
- K023320 — AGILTRAC .035 PERIPHERAL DILATATION CATHETER
- K023391 — BIOPORTA G
- K023469 — VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062
- K023732 — CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K023786 — DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER
- K023811 — MODIFICATION TO VIABAHN ENDOPROSTHESIS
- K023875 — VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
- K023876 — VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
- K021233 — AAP CANNULATED SCREWS
- K021798 — SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
- K022313 — SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V
- K022693 — INSTANT-VIEW TCA URINE TEST
- K023098 — ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT
- K023276 — AMSINO TRACHEOSTOMY CARE TRAY
- K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
- K023362 — FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN
- K023369 — ACCESS TOTAL T4 ASSAY
- K023549 — WIENER LAB AMILASA 405 AA LIQUIDA
- K023550 — WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
- K023551 — WIENER LAB GOT (AST) UV AA LIQUIDA
- K021548 — FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM
- K022997 — SPECTRUM CERVICAL SPINAL SYSTEM
- K023219 — BECTON DICKINSON DIABETES SOFTWARE
- K023281 — ONLINE DAT II COCAINE II
- K023347 — VITAL STIM
- K023389 — PORTA GEO TI
- K023392 — AGC SPECIAL ALLOY
- K023577 — POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G)
- K023661 — LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
- K023789 — O.B. TAMPONS
- K023846 — MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY
- K023891 — ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
- K022985 — ASCENDENT ACETABULAR SYSTEM
- K023007 — DISTAL RADIUS FRACTURE REPAIR SYSTEM
- K023716 — SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
- K023757 — CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
- K021489 — REPIPHYSIS LIMB SALVAGE SYSTEM
- K022048 — INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM
- K022963 — TRANSONIC SYRINGE WARMER, MODEL SYR-1000
- K023016 — NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE
- K023242 — I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE
- K023251 — PEDIATRIC ARTERIAL CANNULA
- K023574 — GIZMO
- K023700 — PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE
- K023718 — QUICKSET MIMIX BONE VOID FILLER
- K023810 — MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- K023871 — M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY
- K020440 — NEWCOR
- K021098 — DAUM-LECTRIC MRI DRILLING MACHINE
- K022176 — ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
- K023067 — IMTEC SENDAX MDI ORTHO6 AND ORTHO8
- K023108 — STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE
- K023380 — T-WAVE ALTERMANS (TWA) ALGORITHM OPTION
- K023798 — MODIFICATION TO ENVOY PATIENT MONITOR
- K020130 — ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M
- K020533 — EXEL VACULET BLOOD COLLECTION SET
- K020837 — MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE
- K021430 — SANIDAD TENS-DUO MODE GP8016N
- K021501 — V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT
- K021859 — WRIST IMPLANT
- K022494 — HOME CARE JELLY
- K022518 — J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT
- K022640 — SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM
- K022698 — SCOOTER MARS SERIES, MODEL TL-588
- K022911 — MODEL AMI1200 C-ARM
- K022933 — EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
- K022952 — MODULAR HEAD BONE SCREW
- K022993 — HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS
- K022995 — COLLATEK HYDROGEL
- K023035 — SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
- K023046 — SST SALIVA SUPPORTING TABLETS
- K023187 — KSEA SPINOSCOPE
- K023327 — CYNOVAD ZIRKON
- K023485 — EXPLORER POWERED WHEELCHAIR
- K023514 — TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH)
- K023517 — DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE
- K023543 — EVLT KIT AND D15PLUS AND D30PLUS DIODE
Data sourced from openFDA. This site is unofficial and independent of the FDA.