FDA 510(k) clearances — page 1042
clearances on record, most recent first.
Clearances — page 1042
104,101–104,200 of 176,637- K946158 — INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
- K950237 — DIGITEST
- K950685 — BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING
- K951069 — SAS SALMONELLA H B ANTISERUM
- K951148 — OBSTI-HOOK
- K951245 — VIDAMED 50 ELECTROSURGICAL GENERATOR, VIDAMED AEC (ADJUSTABLE ELECTROSURGICAL CARTRIDGE) ACCESSORY
- K951391 — IL TEST DIGOXIN, PN 181761-00
- K951631 — DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
- K951859 — ACUFEX ENDOBUTTON PACK
- K951986 — INSULATED ELECTROSURGICAL INSTRUMENTS
- K944709 — W&H 896 TOP LIGH HIGHSPEED
- K946209 — DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME
- K946257 — LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC)
- K951065 — SURGICAL INSTRUMENT MOTOTRS AND ACCESSORIES/ATTACHMENTS
- K951091 — RUSCH ENDOBRONCHIAL TUBE SETS
- K951109 — C-THRU CORONARY GUIDE WIRE
- K951147 — LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER
- K951337 — FIBER HEAD LIGHT FH-300
- K951420 — INCASE EXTENSIBLE BAG--NON-STERILE
- K951787 — DEGUBOND 4
- K952007 — ADHEROL SEPP APPLICATOR
- K952036 — FLEXLIFE
- K952062 — PFT FILTER
- K952169 — SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC
- K952192 — KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES
- K952214 — SIMS INTERTECH HYPERINFLATION BAG SYSTEM
- K952421 — NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS
- K932880 — GRASSI GASTROJEJUNOSTOMY TUBE
- K936310 — ORTHOMET HMC FEMORAL STEM COMPONENT
- K940715 — OSTEONICS OMNIFIT AD HIP STEM SERIES
- K941234 — NON-MYDRIATIC RETINAL CAMERA
- K943497 — CONTRAST 7000 THERAPY SYSTEM
- K943862 — SONICAID MODEL MR-63 AMBULATORY ECG RECORDER
- K944596 — GRAHAM-FIELD ULTRASOUND LOTION
- K944905 — HOLGRATH PLASTIC-HUB, WHITACRE STYLE SPINAL NEEDLE
- K944906 — HOLGRATH PLASTIC-HUB EPIDURAL NEEDLE
- K944907 — HOLGRATH PLASTIC-HUB, QUINCKE SPINAL NEEDLE
- K944908 — HOLGRATH PLASTIC-HUB, COICAL POINT SPINAL NEEDLE
- K945748 — HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY
- K946157 — INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT
- K946159 — INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
- K946237 — ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES
- K950529 — PEREGRINE DIFFUSION LIGHT PIPE
- K950563 — ULTIMA AUGMENTED UHMWPE CUP
- K951043 — AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
- K951323 — VH-2000
- K951489 — MRI'S ALL SILICONE GASTROSTOMY TUBE
- K951678 — HI SONIC 2000 DIGITAL HEARING INSTRUMENT
- K951856 — HUMID-VENT MICRO
- K952207 — NASAL SEPTAL SPLINT
- K935523 — NATURAL-KNEE(R)/APOLLO(TM) KNEE
- K941366 — OSTEONICS OMNIFIT AD-HA HIP STEM SERIES
- K942563 — ELITE BIOFEEDBACK
- K942688 — NEPHRO-URETERAL STENT
- K944999 — SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3
- K945254 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES
- K945956 — STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS
- K946177 — VALLEYLAB NS 2000 BIPOLAR GENERATOR SYSTEM
- K950239 — SENSIMATIC 500SE
- K951112 — PRESSUREGUARD IV
- K951210 — WELCH ALLYN VIDEO OPHTHALMOSCOPE
- K951569 — SURGACTIVATOR
- K951619 — UNIVEC NONREUSABLE LOCKING SYRINGE
- K951663 — TYTIN R
- K951784 — PRIMALLOR 1
- K951785 — PRIMALLOR 2
- K951992 — FAIRY WORLD INC
- K952122 — V-GNATHOS PLUS
- K932050 — NH-2002
- K934913 — HEARTRAC ECG MONITORING SYSTEM
- K943948 — PROTECTIVE SHORTS
- K944602 — VALLEYLAB FORCE FX
- K945379 — PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
- K945594 — DECA DERMATOME (MICROMOTOR SYSTEM)
- K945903 — BRAINLAB MASK SYSTEM
- K946085 — THIN-FILM CARDIAC GATING CABLE
- K946332 — KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION
- K950781 — COMPACT 7600
- K951024 — NATURE'S CRADLE
- K951352 — DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE
- K951804 — KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE
- K951937 — BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM)
- K952060 — QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000
- K952076 — HEMAGEN ENA SCREENING KIT (EIA METHOD)
- K952077 — HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
- K952085 — DPD DEFIBRILLATOR
- K952228 — SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE
- K952263 — PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
- K952466 — OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT
- K933197 — THE SIGNATURE SERIES, M IV
- K933683 — PENTAX FACE MASK
- K941923 — STERILE TREATMENT ELECTRODE
- K942170 — MODEL 511 INFANT MONITOR
- K943358 — NAVIGUIDE HYDROPHILIC GUIDE WIRE
- K943934 — AORTIC ARCH CANNULAS
- K944287 — 7050 ULTRASOUND IMAGING SYSTEM
- K944495 — MODEL 3200 VASCULAR MINI-LAB
- K944708 — W&H 895 TOP LIGH HIGHSPEED FIBEROPTIC SINGLE SPRAY
- K944710 — W&H 898 TOP LIGHT HIGHSPEED
- K944715 — W&H 795 TOP AIR TURBINE SINGLE SPRAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.