FDA 510(k) clearances — page 736
clearances on record, most recent first.
Clearances — page 736
73,501–73,600 of 175,825- K021176 — COMPUMEDICS SOMTE SYSTEM
- K022170 — INNER-LOCK LOCKING INTRODUCER SHEATHS
- K023009 — FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER
- K023131 — FREELITE HUMAN LAMBDA FREE KIT
- K023790 — UCC DENTAL MATERIAL
- K023795 — PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)
- K030074 — LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
- K022035 — OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
- K023138 — HYDROFERA BACTERIOSTATIC WOUND DRESSING
- K023528 — NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
- K023531 — LESSER METATARSAL PHALANGEAL JOINT IMPLANT
- K023533 — BARCO MEDIS 5MP2 AURA
- K023535 — TRIPTER X-1 COMPACT DUET
- K023546 — MAXIM ACCEL KNEE SYSTEM
- K023580 — STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM
- K023609 — SILVERLON ADHESIVE STRIP
- K023649 — VITIQUE SYSTEM
- K023653 — MAXONE IV FLUID/BLOOD WARMER, MODEL 102
- K023689 — CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM
- K023710 — VISORB SWIFT
- K023739 — GLUCOSE-SL-C ASSAY, MODEL 257-30
- K023742 — SCULPTURE PLUS NANO-HYBRID COMPOSITE
- K023745 — SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
- K023748 — FLASH-LITE II LED DENTAL CURING LIGHT
- K023813 — BIPOLAR FORCEPS
- K023892 — MILLEX VV, GV, AND HV SYRINGE FILTER UNITS
- K024018 — AVANT GUARDIAN 101
- K024020 — THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
- K024056 — SURESET 3.0 ML RESERVOIR, MODEL 24-103
- K024218 — LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114
- K024220 — LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
- K024232 — LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
- K024236 — ULTRASOUND SCANNER, TYPE 2400
- K024366 — COALESCENT SURGICAL U-CLIP AND ACCESSORIES
- K030012 — CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
- K030028 — CPC BY SORING GMBH
- K030067 — VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
- K030088 — TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS
- K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE
- K022976 — STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
- K023141 — MODIFICATION TO STANDARD HUMAN PLASMA
- K023213 — RDH-2000
- K023356 — KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
- K023490 — DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL
- K023515 — PRE-POWDERED LATEX SURGEON'S GLOVES
- K023519 — RADIONICS VARILINK 2
- K023544 — GENZYME CONTRAST II HCG URINE/SERUM TEST
- K023682 — ENCLOSE ANASTOMOSIS ASSIST DEVICE
- K023727 — TEMPORARY CEMENT-DC010002
- K023920 — SKINTACT
- K023952 — REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE
- K024200 — INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
- K024247 — SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
- K024264 — SKINTACT
- K021555 — STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
- K023289 — OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
- K023482 — AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500
- K023536 — NUAMPS
- K024067 — RHEUMATOID FACTOR (RF)
- K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES
- K024129 — MODIFICATION TO EBI XFIX DFS SYSTEM
- K024134 — UNI HIP STEM
- K024137 — JUPITER PROCESSING AND REVIEW WORKSTATION
- K024161 — NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS
- K024217 — LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108
- K024219 — LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
- K024221 — LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118
- K024222 — LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112
- K024224 — LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129
- K024225 — LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119
- K024227 — LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127
- K024229 — LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111
- K024230 — LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131
- K024365 — TM2005 PERSONAL MEDICAL PHONE CENTER
- K021992 — DHS DISPOSABLE HOOD SYSTEM
- K022145 — OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
- K023468 — ENDOSCOPIC LIGHT SOURCE XL180/L3
- K023706 — ULTROID HEMORRHOID MANAGEMENT SYSTEM
- K023779 — RSV OIA
- K023834 — HL888
- K023839 — HEMOSIL FACTOR V DEFICIENT PLASMA
- K024126 — CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
- K024156 — PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
- K024173 — CDS 3-PD HEMATOLOGY CONTROLS
- K024184 — POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
- K021794 — TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING)
- K022636 — BODY BOX 5500
- K023163 — LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020
- K023435 — MEDS-4 NEUROMUSCULAR STIMULATOR
- K023439 — MEDS-4 NEUROMUSCULAR STIMULATOR
- K023443 — MEDS-3 NEUROMUSCULAR STIMULATOR
- K023446 — MEDS-3 NEUROMUSCULAR STIMULATOR
- K023449 — NON-INVASIVE PATIENT FIXATION SYSTEM
- K023459 — DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
- K023462 — IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003
- K023464 — VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR
- K023499 — GOLD CORE PLUS
- K023572 — LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET
- K023763 — RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
- K024223 — LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
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