FDA 510(k) clearances — page 683
clearances on record, most recent first.
Clearances — page 683
68,201–68,300 of 175,825- K041157 — MODIFICATION TO SMALL BONE FIXATION SYSTEM
- K041352 — COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
- K041355 — HUMERAL STAPLE
- K041469 — ANTERIOR COMPACT SYSTEM
- K041484 — UNDECIDED
- K041559 — 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55
- K041700 — CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR
- K041707 — CERCON CERAM EXPRESS CERAMIC SYSTEM
- K041828 — APEX MEDICAL CPAP MODEL 9S-003
- K041916 — ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM
- K041949 — ALLURA XPER FD10
- K031397 — MERLIN E-MASK
- K031858 — NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES
- K033614 — MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
- K040992 — 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706
- K041044 — CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
- K041128 — SUTURE ARROW
- K041223 — MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
- K041368 — DENTIUM CO., LTD. IMPLANTIUM
- K041644 — FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)
- K041664 — PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C
- K041815 — LNCS OXIMETRY SENSORS
- K041955 — GEMINI PET/CT IMAGING SYSTEM
- DEN040008 — CEDIA SIROLIMUS ASSAY
- K033313 — QUATRO M FEMORAL COMPONENT
- K033463 — EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
- K033930 — KAPP CUSTOM ULNAR HEAD WRIST IMPLANT
- K040031 — CERAGEM-C THERMAL ACUPRESSURE MASSAGER
- K040417 — PILLAR PALATAL IMPLANT SYSTEM
- K040682 — SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
- K041105 — MACROPORE HYDROSORB SPINE SYSTEM
- K041233 — ARTHROJET XT
- K041274 — RESORBABLE INTERFERENCE SCREW
- K041340 — GUIDANT MICROWAVE ABLATION SYSTEM
- K041399 — HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE
- K041410 — PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
- K041772 — DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES
- K041922 — GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR
- K033592 — REPROCESSED SURGICAL SCISSORS AND GRASPERS
- K040107 — CYTO-CHEX BCT
- K040560 — ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
- K041000 — DUREPAIR DURA REGENERATION MATRIX
- K041103 — ACNELIFT
- K041159 — JMS ABSORBABLE ANCHOR AND APPLICATOR
- K041162 — ORTHO-CMS
- K041326 — MEDCOMMONS OPEN RADIOLOGY GATEWAY
- K041328 — SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR
- K041363 — AOC BONE WAX
- K041534 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL
- K041599 — COBRA ADHERE SURGICAL SYSTEM
- K041600 — QWIKCHECK-BEADS
- K041682 — CAAS MRV
- K041812 — MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)
- K041870 — N APOLIPOPROTEIN STANDARD SERUM
- K030290 — PERIOLASE ND:YAG DENTAL LASER SYSTEM
- K041403 — ECLIPSE WITH AAA
- K041420 — ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
- K041602 — PANORAMA 1.0T
- K041921 — GE SIGNA PROFILE 6 INCH GP COIL
- K031088 — TRIMED PLAN, VERSION 2.2
- K031996 — EXTENTRAC ELITE
- K040019 — SILVERSEAL
- K040483 — EQUESTRA FLUID DELIVERY SYSTEM
- K040754 — AMERICAN BANTEX MS 4 MINI SCOOTER
- K040844 — LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
- K040913 — NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
- K040979 — ELEKTA MICRODRIVE, MODEL 916716
- K041070 — STRAUMANN TEMPORARY COPING
- K041138 — LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
- K041167 — PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
- K041312 — NOBELRONDO DENTAL CERAMIC-ALUMINA
- K041465 — SINON SN-L402 LIGHTWEIGHT WHEELCHAIR
- K041523 — XPS 3000 SYSTEM
- K041665 — L1-PRO SYSTEM
- K041675 — PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS
- K041678 — KARMA POWER WHEELCHAIR, MODEL KP-25
- K041695 — LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE
- K041726 — HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX
- K041727 — MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
- K041750 — PTS PANELS CHOL+GLU TEST PANEL
- K041790 — DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE
- K041813 — GE LOGIQ 7 ULTRASOUND BT04
- K041842 — NORIAN SRS FAST SET PUTTY
- K041907 — TRIO MONITOR
- K041942 — M2376A DEVICELINK SYSTEM
- K040565 — PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE
- K040766 — OPTISOURCE, MODEL 1032P
- K040923 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
- K040931 — PATXFER RT
- K040978 — TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE
- K040991 — AMBU DISPOSABLE PRESSURE MANOMETER
- K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY
- K041150 — MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS
- K041151 — KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES
- K041213 — 3DSCOPE
- K041232 — GETTIG UNIVERSAL VIAL ACCESS PIN
- K041345 — PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES
- K041439 — SAS INFLUENZA B TEST
- K041441 — SAS INFLUENZA A TEST
- K041453 — SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023
Data sourced from openFDA. This site is unofficial and independent of the FDA.