FDA 510(k) clearances — page 831
clearances on record, most recent first.
Clearances — page 831
83,001–83,100 of 175,890- 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
- K000783 — DIRECT TIBC CALIBRATOR
- K000805 — KAVO K.E.Y. LASER 1242
- K000816 — SHARP BRAND ACUPUNCTURE NEEDLES
- K000939 — HTF-HEPES
- K000940 — HUMAN SERUM ALBUMIN (HSA)
- K001248 — MULTI-PULSE 2000
- K980672 — SIMPLEX AIRBRATOR (SAB-7)
- K991327 — MEDI-CULT FLUSHING MEDIUM
- K991332 — MEDI-CULT SPERM PREPARATION - MEDIUM;
- K992592 — A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
- K993816 — BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD
- K993841 — CEMSTOP CEMENT RESTRICTOR
- K994126 — MODULAR-PLUS REVISION STEM
- K000140 — CLINI-DENT
- K000333 — STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD
- K000348 — COLORADO MICRODISSECTION NEEDLE
- K000349 — MOTORIZED MICRO MULTILEAF COLLIMATOR
- K000380 — FOTOMASTER
- K000395 — EINSTEIN PROCESSING AND REVIEW WORKSTATION
- K000438 — MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER
- K000547 — ATR TECNIKA
- K000579 — TEMPO AQUA ANGIOGRAPHIC CATHETER
- K000681 — AU5, AU6
- K000745 — SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
- K000771 — DIMAX 2
- K000778 — ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01
- K000896 — POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS
- K000966 — 4631 DUO DELIVERY SYSTEM
- K000967 — 4635 ASSISTANT'S INSTRUMENTATION
- K000968 — 3181 DUO DELIVERY SYSTEM
- K001057 — AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR
- K001083 — GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4
- K001140 — IDS5 IMAGE DISPLAY SYSTEM
- K001153 — MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM
- K001238 — LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
- K991422 — POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
- K993520 — H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
- K000320 — SONOS AIRES 600 (SA-600)
- K000327 — WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
- K000480 — ACTIVE ELECTRODE MONITORING SYSTEM
- K000545 — SENTRY EXPANDING INTRODUCER SHEATH (EIS)
- K000663 — KRONNER LOW PROFILE SCOPE HOLDER
- K000665 — TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
- K000672 — HELIODENT VARIO
- K000781 — DIRECT TIBC KIT
- K000900 — ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
- K001266 — VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA
Data sourced from openFDA. This site is unofficial and independent of the FDA.