FDA 510(k) clearances — page 773
clearances on record, most recent first.
Clearances — page 773
77,201–77,300 of 175,825- K014184 — MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
- K014209 — PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS
- K014222 — ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD
- K992099 — BIO SPA INTELLIGENT
- K011355 — BIOLIGHT PCD
- K011771 — RANDOX THEOPHYLLINE
- K011839 — DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C
- K012012 — ECG HOME
- K012037 — HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009
- K012139 — VAMOS ANESTHETIC GAS MONITOR
- K012580 — ERCHONIA PL2000
- K012759 — INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325
- K012789 — MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
- K012804 — PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
- K012879 — EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE
- K012884 — DILATING TIP OBTURATOR
- K013459 — MODIFICATION OF NC-STAT
- K013460 — SWIFT LOW PROFILE CUP (PRO CUP)
- K013461 — NLITE SYSTEM,MODEL A00-1025
- K013477 — TOCO LITE, MODEL TD-01
- K013485 — MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1
- K013490 — CEMENTED CALCAR HIP SYSTEM
- K013498 — CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K013513 — DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE
- K013519 — SIMPLE
- K013539 — ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS
- K013554 — POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K013571 — MAGICFIL
- K013583 — ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS
- K013625 — PERMACOL
- K013835 — GLOBAL HEALTHCARE VAGINAL SPECULUM
- K013841 — 3DFIS, MODEL IES-FL-101
- K013870 — SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224
- K014061 — SIMPLICITY STARPLUS SOFT INFUSION SET
- K014062 — SIMPLICITY EASY ACCESS INFUSION SET
- K014136 — MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
- K014145 — MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131
- K014148 — SELF-DRILLING RADIOGRAPHIC MARKER
- K014157 — HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
- K014194 — MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
- K014212 — BARD CONQUEST PTA BALLOON DILATATION CATHETER
- K014213 — SIEMENS INFINITY GATEWAY SUITE
- K014225 — BREATHTEK - UBIT UBT FOR H. PYLORI
- K014234 — MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER
- K011562 — LUMEND PERCUTANEOUS CATHETER
- K012486 — OSTEOMED BIORESORBABLE FIXATION SYSTEM
- K013052 — KONICA LASER IMAGER, DRYPRO MODEL 751/752
- K013560 — SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9
- K013609 — NEXUS 2 CLEAR
- K013647 — REVOLUTION FORMULA 2
- K013656 — PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
- K013833 — HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096
- K013838 — KSEA CLEARVISION LENS IRRIGATION SYSTEM
- K014122 — HL168E
- K014124 — NUMED COEFFICIENT PTV CATHETERS
- K014137 — MODIFICATION TO EBI OMEGA 21 SYSTEM
- K014206 — LOGIQBOOK
- K011648 — RANDOX CARBAMAZEPINE
- K011649 — RANDOX VALPROIC ACID
- K013442 — PASS SPINAL SYSTEM
- K013447 — ISOBAR SPINAL SYSTEM
- K013448 — PRISMASATE
- K013574 — ACCENT
- K013729 — STAT PROFILE PHOX BASIC ANALYZER
- K013978 — SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
- K014161 — SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
- K014162 — MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
- K014181 — M2376A DEVICELINK SYSTEM, MODEL M2376A
- K013425 — HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A
- K013439 — ANTERIOR CERVICAL PLATE SYSTEM
- K013450 — NOTTA AMBULATORY RECORDER
- K013483 — INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT
- K013500 — KAVO POLYLUX II
- K014146 — 84 CHANNEL EEG
- K014147 — 80 CHANNEL EEG
- K014205 — MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
- K003311 — NUTRISAFE PUR ENTERAL FEEDING TUBE
- K011597 — SMARTMONITOR 2, MODEL 4000
- K012112 — RANDOX DIGITOXIN
- K013391 — BODYFIX
- K013415 — SYNTHES ANKLE ARTHRODESIS PLATE
- K013429 — ACTAEON PROBE
- K013462 — HYDROFERA BACTERIOSTATIC WOUND DRESSING
- K013598 — REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES
- K014094 — MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
- K014117 — MODIFICATION TO OUTBACK CATHETER
- K014118 — MODIFICATION TO SUPERCROSS CATHETER
- K014121 — WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
- K010033 — LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107
- K010577 — BODYGEM, MODEL HB211
- K012075 — IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6
- K012077 — IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
- K012745 — TRIAGE TOX DRUG SCREEN, CATALOG #94000
- K013078 — ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
- K013383 — BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM
- K013389 — DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
- K013416 — INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY
- K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P
- K013478 — DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM
- K013515 — INFINITY EXPLORER
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