FDA 510(k) clearances — page 1014
clearances on record, most recent first.
Clearances — page 1014
101,301–101,400 of 175,890- K954196 — UNIVERSIX 120
- K954521 — MAMMOSPOT PADDLE
- K952482 — KSEA REVERSE VIDEO
- K952897 — NIOMED SHOE COVERS
- K952937 — NIOMED NON-SKID SHOE COVERS
- K953032 — LUNAR DPX DENSITOMETER
- K953248 — IRIS BILATERAL TMJ
- K953377 — DISTENTION BALLOON
- K953664 — VITALOCK SPIKED ACETABULAR SHELL
- K953992 — LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE
- K954024 — CHEMSTRIP CRITERION URINE ANALYZER
- K954178 — OSOM PREGNANCY TEST
- K954187 — TRIGLYCERIDES REAGENT
- K954193 — SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET
- K954212 — CONTAMINATION CONTAINMENT DRAPE
- K954217 — ARTHROPLAST & ARTHRO-CUTTER
- K954251 — 5F ENVOY GUIDING CATHETER (MODIFICATION)
- K954414 — CENTRALITE BACKPOINTER
- K954435 — WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES
- K954458 — BOAT NOSE OBTURATOR
- K954459 — CONICAL OBTURATOR
- K954463 — DISSECTING OBTURATOR
- K954464 — CARPAL TUNNEL SLOTTED CANNULA
- K954475 — BLUNT DISSECTOR, CURVED
- K954476 — PROBE
- K954621 — RECLOSABLE WOUND COVER
- K954633 — CONMED ELECTROSURGICAL GROUNDING PAD
- K954693 — MEHTA BRONCHIAL BIOSPY DRILL
- K934866 — HYS-SURGIMAT
- K944689 — ZIRCONIA CERAMIC FEMORAL HEAD
- K945677 — IL682, CO-OXIMETER
- K945857 — PROTEIN C DEFICIENT PLASMA
- K946335 — OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES
- K951105 — KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
- K951542 — DIRECTIGEN 1-2-3 GROUP A STREP TEST
- K951820 — THROMBOPLASTIN-LI REAGENT
- K952178 — PH-DETECT TEST
- K953264 — QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
- K953437 — OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT
- K953472 — NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR
- K953490 — TRILOGY ACETABULAR SHELL & LINERS 36MM
- K953638 — O.B. APPLICATOR TAMPONS
- K953772 — BREATHE RIGHT NASAL STRIP
- K953903 — LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM
- K954194 — DISPOSABLE HME/FILTER
- K954257 — QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
- K954680 — ACCESS PROLACTIN ASSAY (MODIFICATION)
- K935454 — DPX TISSUE QUANTIFICATION OUTPUT
- K940003 — VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT
- K942651 — BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS
- K944595 — CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
- K945775 — BOEHRINGER AUTOVAC(R) 7900 SERIES
- K950566 — DECOMAT 4656
- K951025 — PISTON SYRINGE
- K951483 — CPR MICROMASK
- K951496 — CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER
- K951627 — INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM
- K952117 — EPILATOR
- K952474 — EAGLE 3000 PATIENT MONITOR
- K952628 — ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS
- K953415 — 6200 VITAL SIGNS MONITOR
- K953572 — ELX800UV
- K953732 — TECA PREMIERE
- K953749 — MEDI-OXIDE STERILZATION POUCH FROM MEDI-PLUS
- K953986 — POWDERFREE LATEX GLOVE
- K954189 — EASI-JECTOR CONTROL SYSTEM
- K954299 — BUHLMANN ANGIOSTENSIN II RIA
- K954373 — AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE
- K954374 — AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM
- K954561 — XENON NOPPVA
- K954643 — TRY-IN GEL
- K943101 — GALVANIC SKIN RESPONSE DEVICE
- K945983 — BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS
- K951117 — LIHTAN 532 LASER
- K952611 — STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION
- K952736 — PERCENT OXYGEN SENSOR
- K953294 — CANDELA CRYOSYSTEM CS-5
- K953371 — LUMISYS DICOM TOOKLIT
- K953533 — RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
- K953554 — NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES
- K953602 — SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER
- K953869 — POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE
- K953889 — AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD
- K953910 — PHILIPS BV 300 SERIES
- K954076 — MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS
- K954252 — EASY BREATHING NASAL STRIPS
- K954263 — XE-LITE
- K954310 — BLA-800A
- K954345 — DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR
- K954484 — KODAK AUTOMIXER II PLUS
- K954526 — WIDEX SENSO DIGITAL (PX)
- K930530 — INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC
- K935892 — INDURENT GEL
- K945445 — BOBES SLIT LAMP
- K950073 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM
- K951665 — PP-SPF1 / PP-SPF2
- K951753 — MEDTEC AUTOBLOT 2000
- K952621 — EML105 ELECTROLYTE METABOLITE ANALYZER
- K953262 — QD BILATERAL BREAST COIL
- K953359 — TRI-STAR UNIVERSAL I/A PHACO PAK
Data sourced from openFDA. This site is unofficial and independent of the FDA.