FDA 510(k) clearances — page 838
clearances on record, most recent first.
Clearances — page 838
83,701–83,800 of 176,637- K993699 — THE STRIPPER
- K000078 — JETLITE 4000
- K000179 — NUZONE NITRILE SURGICAL GLOVES POWDER FREE
- K000399 — STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
- K000493 — STRYKER IRRIGATION TUBE SET
- K000503 — MEDART 520 COOLING SYSTEM
- K000510 — ART-M1, MODEL M1-1-ART-A1
- K000607 — SOLO-CARE BRAND HARD SOLUTION
- K000926 — EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
- K000928 — QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K001232 — NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS
- K001239 — ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K001280 — COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES
- K001444 — STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103
- K993732 — BVBLUE
- K993760 — POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS
- K994334 — ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX
- K000162 — METRISCAN BONE DENSITY SYSTEM
- K000281 — WALLSTENT ENTERNAL PROSTHESIS
- K000485 — HYDRO2, HS-75
- K000630 — MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM
- K000819 — PHILIPS CT SECURA MV
- K000905 — URETHROTOME 8667.XXX AND 8670.XXX
- K000915 — PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
- K000948 — OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
- K000950 — EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
- K001171 — DELTA 16 TACT
- K001198 — DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET
- K001208 — ESPIRT
- K001267 — GE SYSTEM FIVE
- K001368 — PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
- K992178 — BALLOON FOR ULTRASONIC ENDOSCOPES
- K992192 — AIRPILOTMASK, MODEL TMS-900
- K992823 — SPIROVIT SP-2, PNEUMOCHECK II
- K000189 — PQ1
- K000590 — LATERAL PIVOT INSERT
- K000636 — STRYKER TRAUMA PLATING SYSTEM
- K000658 — ERS RADIAL HEAD REPLACEMENT
- K000694 — PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)
- K000706 — DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
- K000710 — MD 10, SEM, SM 12, CBM
- K000965 — MULTI-AXIAL CROSS (MAC) CONNECTOR
- K001030 — RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S
- K001055 — MODEL 4300 PSARRAY EEG ELECTRODE SET
- K001145 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
- K001196 — JEL BIOS 90 (CODE NAME RD-2401)
- K001197 — COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
- K001272 — XIA SPINE SYSTEM
- K991886 — PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
- K992819 — WAND PLUS
- K993815 — UNI-LASER 430
- K994362 — HEADLAMP HL2000.
- K000472 — POSI-LINK
- K000514 — RUMBAR DRAINAGE SYSTEM
- K000521 — KEYSTONE HIP
- K001139 — PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
- K991031 — COLORADO II SPINAL SYSTEM
- K000216 — PSK ENDOSCOPE CLEANING SYSTEM
- K000263 — GO MEDICAL BALLOON INFUSION SYSTEM
- K000328 — MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP
- K000451 — FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
- K000457 — VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES
- K000749 — RHIGENE MESACUP2 TEST- SSA
- K000750 — RHIGENE MESACUP2 TEST- SCL-70
- K000751 — RHIGENE MESACUP2 TEST- SSB
- K000752 — RHIGENE MESACUP2 TEST- RNP
- K000755 — RHIGENE MESACUP2 TEST- SM
- K001141 — POWDER FREE STERILE LATEX EXAMINATION GLOVES
- K001212 — TROJAN EXTRA LARGE LATEX CONDOM
- K001241 — EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
- K991471 — MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015)
- K991472 — MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079
- K994140 — NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
- K000416 — TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
- K000420 — SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
- K000190 — MODIFICATION TO CARTO EP NAVIGATION SYSTEM
- K000248 — CARTO EP NAVIGATION SYSTEM
- K000386 — POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
- K000577 — YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA
- K000578 — SERIM LEUKOCYTE ESTERASE TEST STRIPS
- K000606 — SYNCHRON SYSTEMS AMPHETAMINE REAGENT
- K000734 — PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601
- K000897 — CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
- K001100 — BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH
- K001144 — ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
- K001263 — SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040
- K001293 — MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE
- K001310 — VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
- K991293 — EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
- K991801 — BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
- K991802 — BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
- K991803 — BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
- K991804 — BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
- K993678 — THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES
- K994243 — DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP
- K994433 — CONNECT DATA MANAGEMENT SYSTEM
- K000332 — NOGA CARDIAC NAVIGATION SYSTEM
- K000368 — EYECAP IMAGING SYSTEM
- K000587 — SHUTTLE STOP
- K000691 — VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS
Data sourced from openFDA. This site is unofficial and independent of the FDA.