FDA 510(k) clearances — page 860
clearances on record, most recent first.
Clearances — page 860
85,901–86,000 of 175,890- K991426 — MAHE INSTRUMENTS
- K991505 — MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
- K991516 — MICRO-STRIP FOR MARIJUANA METABOLITES
- K991594 — CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
- K991845 — PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.
- K991846 — PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE
- K991871 — HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
- K991981 — NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR
- K992002 — AUTOHDL CHOLESTEROL REAGENT SET
- K992017 — DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
- K992019 — LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K992157 — CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
- K992362 — FLEXISCOPE IQ 101
- K973707 — ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
- K991028 — CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
- K991747 — QUICKVUE ONE-STEP H. PYLORI II TEST
- K991903 — EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
- K991929 — INTRASTENT
- K992275 — FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
- K992289 — VINYL POWDERED EXAM GLOVE / CAT.# 15-020
- K974728 — INTER-OP METASUL ACETABULAR SYSTEM
- K990619 — RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE
- K991371 — CARESIDE AMMONIA
- K991566 — SOLUSTAPLE
- K991569 — HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2
- K991642 — EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
- K991652 — HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM
- K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
- K992387 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100
- K992388 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200
- K990854 — INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE
- K990942 — DUET II GLUCOSE CONTROL MONITORING SYSTEM
- K991157 — N LATEX STFR REAGENT
- K991565 — TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S
- K991629 — GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C
- K991724 — QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64
- K991740 — OPART, MODEL MRT-600
- K991765 — SYNERGY SHOULDER COIL
- K991805 — ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION
- K991866 — BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
- K991867 — INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
- K992318 — MEDTRONIC AVE BRIDGE STENT
- K992438 — INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
- K982859 — UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM
- K983802 — LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB
- K984054 — AGC V2 REVISION KNEE SYSTEM
- K984482 — AVE GL-1 GUIDING CATHETER
- K990142 — HT, MODEL HT PB
- K990345 — RABEA DEVICE, MODEL PXXXXXX
- K990680 — DENTEC LD 15 DIODE LASER
- K990770 — BIORC ANCHOR
- K990914 — POLARIS DIODE LASER SYSTEM AND ACCESSORIES
- K991073 — ACIER SUTURES
- K991520 — FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION
- K991523 — TLC PEDIATRIC FRAME, MODEL TLC-SYS
- K991535 — CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
- K991546 — AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD
- K991581 — NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO
- K991615 — POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE
- K991625 — KOMET XK-95 PERFORATOR MOTOR (MI-102)
- K991708 — ZIRCONIA 22.22MM CERAMIC MODULAR HEADS
- K991725 — SIDESTREAM NEBULIZER
- K991763 — LACTOSORB HAND SYSTEM
- K991870 — ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
- K991874 — EMS SURFACE MOUNT SCALER
- K991933 — DERMAPHYLYX FOAM ISLAND DRESSING
- K991937 — ULTRASOUND SCANNER, MODEL TYPE 2101
- K991968 — CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
- K992018 — LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
- K992037 — MAMEX
- K992061 — PULSTAR
- K992146 — SCARAID SILICONE GEL SHEETING
- K992186 — QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT
- K992218 — DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601
- K992219 — POWDERED LATEX STERILE SURGICAL GLOVES
- K992227 — CRIT-LINE MONITOR III (CLM III)
- K992277 — STAPLETAC BONE ANCHOR SYSTEM
- K992288 — AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE
- K992344 — OSTEONICS ACCP SYSTEM LINE EXTENSION
- K992353 — BLUNT TIP TROCAR PORT
- K992408 — ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES
- K983120 — BICORTICAL SCREW
- K984506 — SD-100 SKYEAR THERMOMETER
- K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
- K991533 — MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION
- K991591 — BIOTHANE PATIENT RESTRAINT
- K991659 — UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES
- K992100 — PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED
- K992177 — NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE
- K992189 — GORE-TEX DUALMESH BIOMATERIAL
- K992206 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K992300 — QUICK-SERTER, MODEL 395
- K983270 — VOYAGER QUAD CANNULA
- K984188 — AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
- K984501 — DADE BEHRING BFTII
- K990580 — CRYOCHECK LA SURE, MODEL SUR25-10
- K991497 — ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
- K991503 — SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36
- K991702 — MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578
- K991945 — PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01
Data sourced from openFDA. This site is unofficial and independent of the FDA.