FDA 510(k) clearances — page 598
clearances on record, most recent first.
Clearances — page 598
59,701–59,800 of 176,637- K071534 — CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS
- K071639 — QWIX POSITIONING SCREW
- K071870 — HEXAPOD RT COUCH TOP
- K062616 — WELLNESSPRO 2010
- K070915 — SAPIMED DISPOSABLE SIGMOIDOSCOPE
- K071107 — GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON
- K071318 — MODIFICATION TO: STOCKERT S5 SYSTEM
- K071698 — AURORA LED SERIES SURGICAL LIGHTS
- K071743 — PILLAR PEDICLE SCREW SYSTEM
- K043579 — ATRICURE BIPOLAR SYSTEM
- K062584 — PRESSIO ICP MONITORING SYSTEM
- K070317 — ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
- K070663 — A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT
- K070811 — CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000
- K070983 — OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM
- K071022 — POWDER-FREE VINYL EXAMINATION GLOVES
- K071088 — LIFE LATCH SHARPS & BIOHAZARD CONTAINER
- K071113 — RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053
- K071542 — DIGITAL STEREOLOC II
- K071574 — STIFFER COAXIAL MICRO-INTRODUCER KIT
- K071717 — GE OEC ALTITUDE
- K062377 — MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100
- K062824 — AOS UNIVERSAL CONECTING GUIDE TUBE
- K063063 — SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION
- K070298 — MODIFICATION TO PALOMAR LUXIR HANDPIECE
- K070689 — LG SPERM FREEZING
- K070730 — FLEX-NECK ARC CATHETER
- K070973 — QUANTUM SPINAL SYSTEM
- K070978 — ZIMMER SEGMENTAL SYSTEM
- K071155 — MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER
- K071156 — SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER
- K071253 — AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
- K071622 — ARTHREX FIBERWIRE
- K071675 — LIQUICHEK TUMOR MARKER CONTROL
- K063133 — CRANIAL SOLUTION ORTHOSIS
- K063837 — SIGMA M
- K070516 — POWERLASER
- K070743 — Z6 STIMULATOR
- K070846 — MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM
- K070903 — MYLAB40
- K071334 — DEPUY CAS HEMI ASR HIP INSTRUMENTS
- K071569 — ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER
- K071645 — MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
- K061123 — PALM ECG RECORDER, MODEL EP-201/202
- K063339 — MEDICK MHM200 PERSONAL HEART MONITOR
- K063526 — A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
- K063681 — TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE
- K070351 — SPACE 360 DELIVERY SYSTEM
- K070426 — SILHOUETTE, MODEL 1000.01
- K070559 — POLYMAP PWR-08-03
- K070613 — ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
- K070648 — THE INHIBITOR, MODEL 001
- K070696 — INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
- K070699 — AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN
- K070744 — NARROW NECK TEMPORARY COPING
- K070770 — GORE BALLOON SHEATH
- K070890 — EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
- K070921 — BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
- K071024 — MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
- K071030 — BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC
- K071050 — GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM
- K071053 — RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
- K071058 — MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
- K071066 — SPYCATCH STONE RETRIEVAL BASKET
- K071090 — TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
- K071177 — ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW
- K071226 — 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043
- K071234 — ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F
- K071257 — MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD
- K071278 — EMBRACE DUAL CURE COMPOSITE MATERIALS
- K071352 — CERADRILL
- K071394 — MODIFICATION TO:SBI RINGFIX
- K071488 — REALHAND HIGH DEXTERITY (HD) INSTRUMENTS
- K071495 — EXPEDIUM 4.5MM SPINE SYSTEM
- K071497 — ATLAS SPINE VERTEBRAL BODY REPLACEMENT
- K071543 — HALO360' COAGULATION CATHETER
- K061239 — EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT
- K061496 — SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
- K062630 — OSSIPRO BONE SUBSTITUTE MATERIAL
- K063670 — MODIFICATIONS TO CD HORIZON SPINAL SYSTEM
- K070786 — X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
- K071396 — CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
- K071433 — SMS GLUCOSE CONTROL, MODEL 2120059
- K071506 — ECHELON SPECTROSCOPY PACKAGE
- K071611 — NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL
- K062878 — EZPACS, VERSION 3.0
- K063768 — TITANIUM SCALLOPED ABUTMENT
- K070619 — POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING
- K071103 — HABIB HEXABLATE
- K071436 — REGIUS UNITEA
- K071570 — GE LUNAR BODY COMPOSITION SOFTWARE
- K070572 — ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM
- K070672 — MASSAGE MATTRESS VM9100RM
- K070791 — PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS
- K070849 — DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
- K071268 — MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE
- K071319 — I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02
- K071513 — INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
- K071523 — FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750
- K071607 — ASA01 HEAVY DUTY SUCTION PUMP
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