FDA 510(k) clearances — page 707
clearances on record, most recent first.
Clearances — page 707
70,601–70,700 of 175,825- K021594 — COPC BAND
- K031170 — POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BROTHERS
- K031546 — RAINBOW GT-4A PAIN RELIEF MACHINE
- K031793 — DENTATUS OSCIOMAT
- K032444 — NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY
- K032460 — PROFILE BBL SYSTEM
- K032476 — NUVASIVE MESH
- K032691 — ZOLL AUTOCLAVABLE INTERNAL HANDLES
- K032744 — ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
- K032781 — BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K032783 — BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
- K032809 — HOSPITAL SPACER
- K032824 — STELKAST UNICONDYLAR KNEE SYSTEM
- K032879 — NAVIGATOR I
- K032921 — PREMISE
- K032934 — MPS ACACIA SAFEGUARD HUBER DEVICE
- K032964 — EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS
- K033144 — DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES
- K033252 — MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
- K033373 — MONOJECT INSULIN SYRINGE
- K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82
- K023120 — OXYCON MOBILE
- K031494 — DOC'S BEST WHITE COPPER CEMENT
- K031559 — RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES
- K031798 — GOOD MORNING TEST
- K031799 — MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881
- K031820 — ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660
- K032512 — Y.E.S POWERED WHEELCHAIR. T180
- K032519 — ENDO PAT 2000
- K032520 — ORTRAUTEK TRAUMA SYSTEM
- K032617 — WU'S 4-WHEELED SCOOTER, WT-L4JR
- K032627 — ULTRADENT CITRIC ACID 10% SOLUTION
- K032646 — ELECSYS PROBNP IMMUNOASSAY
- K032669 — Y.E.S. POWERED WHEELCHAIR, MODEL T200
- K032852 — MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
- K032861 — VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
- K033021 — KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS
- K033066 — XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
- K033097 — TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02
- K033199 — COMPACT DIGITAL CARDIAC CAMERA (CDCC)
- K033204 — ESG 4-WHEEL SCOOTER, ESG-03
- K033219 — BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600
- K033239 — BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
- K033304 — MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
- K033347 — MODIFICATION TO: HI-ART SYSTEM
- K033434 — BESTALOY
- K033435 — E-SARANG 86, DM78, DM55
- K030583 — POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE
- K031385 — ANZAI AZ-733 RESPIRATORY GATING SYSTEM
- K031795 — RELIANT LASER SYSTEM
- K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
- K032308 — BLOOD PRESSURE MONITOR, MODEL M100
- K032475 — SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
- K032536 — SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
- K032607 — POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
- K032823 — MEDICHEART, MODEL RELEASE 1
- K032867 — STAR (LUNAR SERIES) MONITORING SYSTEM
- K032871 — PLANET MONITORING SYSTEM
- K032880 — SUMMIT STAIRWAY LIFT
- K033032 — WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR
- K033241 — BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320
- K033334 — PROFILE -ER
- K033393 — ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
- K033418 — TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
- K033427 — MODIFICATION TO EN-BLOC BIOPSY SYSTEM
- K032455 — PANAVIA F 2.0
- K032473 — DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE
- K032647 — ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA
- K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
- K032873 — PROCLEAR COMPATIBLES MULTIFOCAL
- K033061 — CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
- K033385 — DGH 55 HANDHELD PACHYMETER (PACHMATE)
- K033430 — 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615
- K030359 — KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K030419 — VITERION 100 TELEHEALTH MONITOR
- K033245 — BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
- K033271 — DYNALOK CLASSIC SPINAL SYSTEM
- K033275 — LIFEPAK 12, 20, 500, CR PLUS
- K033325 — AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
- K033365 — APEXPRO FH TELEMETRY SYSTEM
- K033374 — LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
- K033425 — AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
- K031073 — PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE
- K032130 — VITOSS-FILLED CARTRIDGE
- K032425 — INVISIJECT RESUSABLE AUTO-INJECTOR
- K032439 — ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
- K032470 — MULTILINK
- K033034 — VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
- K033071 — SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
- K033093 — ECHOCONNEX COMMUNICATOR
- K033102 — MEDIC COLON MODEL, RELEASE 1
- K033112 — WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS
- K033145 — HOFFMANN II PELVIC CLAMP
- K033158 — SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
- K033224 — HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
- K033233 — LACTOSORB TIBIAL L-15 SCREW AND WASHER
- K033247 — MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
- K033300 — VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS
- K033321 — SELECTIVA SB GUIDEWIRE
- K033361 — VIATRONIX V3D VASCULAR, REVISION 1.0
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