FDA 510(k) clearances — page 1285
clearances on record, most recent first.
Clearances — page 1285
128,401–128,500 of 176,637- K896978 — CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE
- K897084 — CONFEES(R)+ CONTACT LENS HOLDER
- K897085 — COMFEES(R) + CON-PAK(TM) LENS CASE
- K900282 — NEEDLE-SHIELD
- K900387 — DISCO SUNGLASSES (NON-PRESCRIPTION)
- K900426 — IV BIFURCATED EXTENSION SET
- K900427 — IV TRIFURCATED EXTENSION SET
- K890019 — LATEX SURGICAL GLOVES
- K894248 — CONVERTER SYSTEM
- K895411 — OPTIKEM PMMA CONTACT LENS
- K896193 — TECNOL LAZER(TM) SURGICAL MASK
- K896232 — COBAS READY TOTAL BILIRUBIN REAGENT
- K896235 — COBAS READY ALBUMIN REAGENT
- K896236 — COBAS READY BUN REAGENT
- K896355 — CMV IGM ELISA TEST SYSTEM
- K896676 — KEY VASCULAR LOOPS
- K896777 — RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE
- K896778 — RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE
- K896956 — QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3
- K897110 — SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM
- K900004 — CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3
- K900006 — CATHETER ADAPTER SEALING CAP NO. 48-1028-9
- K900129 — MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*
- K900259 — DIRECT BILIRUBIN REAGENT
- K900384 — INFRAVIB MASSAGER - MODEL PR-1000
- K900419 — CRYOTRON-UL30
- K900422 — TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
- K900514 — JYROCHAIR POWER WHEELCHAIR
- K900523 — MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP.
- K900525 — MODEL F 1 FLIP-UP SUNGLASSES W/POLYCARBONATE BLUE
- K900579 — AUTOREADER CALIBRATION TEST PLATE
- K895044 — DUAL GUIDE INTRODUCER CATHETER
- K895379 — LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
- K895688 — NOBLES-LAI ENGINEERING INFUSION PUMP
- K896005 — SMALL CATHETER INFLATOR
- K896097 — VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
- K896373 — 1400 SERIES EVIDENCE COLLECTION KIT
- K896703 — TBD IONTOPHORESIS ELECTRODE
- K896726 — 4 SURE EXTERNAL MALE CATHETER
- K896740 — AXIAL AND OFFSET CROSSLINK PLATES
- K896761 — TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1
- K896763 — CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1
- K896764 — UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5
- K896771 — EKG, ECG KENZ, ECG 302
- K896772 — EKG, ECG KENZ, ECG 303
- K896806 — CATHETER PLUG/PROTECTOR
- K896875 — POSITIVE AND NEGATIVE HCG SERUM CONTROLS
- K896885 — DISPOSABLE RESPIRTORY KIT (MP-200)
- K896907 — 3M IV FLOW REGULATOR
- K896951 — SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM
- K897026 — CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO.
- K897150 — LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT
- K900233 — TCT-300S - UPGRADE
- K900234 — PFM-90 CEILING TUBE SUPPORT
- K900251 — REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175
- K900367 — HOFMANN-NAGEL (HOFNA) X-RAY TUBES
- K900440 — AIA-PACK BMG
- K900620 — DU PONT MAMMOGRAPHY CASSETTE
- K900625 — MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET
- K900741 — BIODEX BACK SYSTEM ATTACHMENT
- K894992 — QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM
- K895147 — QUANTUM QAD-1E ANGIODYNOGRAPH ULTRASOUND SYSTEM
- K895274 — HYPEX
- K896387 — SXT-60F/60M MOBILE C ARM X-RAY UNIT
- K896744 — BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC
- K896812 — CARBON DIOXIDE REAGENT
- K896829 — TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD)
- K896834 — MODEL BT-1 FOT BOLT INSTALLATION KIT
- K896867 — THYROID STIMULATING HORMONE-EIA-XT
- K896948 — ALPHA-STIM CS
- K896954 — ABBOTT SPECTRUM URIC ACID REAGENT KIT
- K897098 — SIEMENS ENDO-P-PROBE
- K897165 — COULTER AST (GOT) REAGENT
- K897166 — COULTER TOTAL PROTEIN REAGENT
- K897169 — QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT
- K900372 — BIOTRACK IMMUNOCHEMISTRY MONITOR
- K900498 — MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
- K900586 — MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE
- K900617 — SERATEST ENA [SSA] KIT
- K893229 — SPATULA FOR PAP SMEAR COLLECTION
- K895001 — TYPE EXPIRED CO2 9270, CAPNOGRAPH
- K895230 — STERILE SURGEON'S GLOVES (C T R GLOVES)
- K895269 — DEN-MAT LAMI-QUICK
- K895638 — STEAM STERILIZER (AUTOCLAVE), DENTAL
- K895656 — ACCU-BEAM WAVEGUIDE
- K895740 — SHOWER CHAIRS; BED/STRETCHER; LINEN & UTILITY CART
- K895895 — MODEL 219 TELEMETRY SYSTEM
- K895955 — LOPER CELIAC PLEXUS BLOCK CATHETER KIT
- K895971 — TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING
- K895987 — KELLER PULSE OXIMETER - KMS 850
- K896397 — S-ROM(TM)/NOILES(TM) MARK 5 KNEE
- K896649 — GRANITEC Z2, ZINC PHOSPHATE CEMENT
- K896667 — LORENZ STENT
- K896718 — BICORE VARIFLEX(R) FLOW TRANSDUCER
- K896719 — PRIMER-P ADHESIVE AGENT
- K896798 — TRACHEOSTOMY TRAY
- K896961 — HALUX EXLITE MINOR SURGERY LIGHT
- K897152 — CRAGG CONVERTIBLE WIRE
- K897157 — OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM
- K900059 — BIOPOTENTIAL SURFACE ELECTRODE
Data sourced from openFDA. This site is unofficial and independent of the FDA.