FDA 510(k) clearances — page 675
clearances on record, most recent first.
Clearances — page 675
67,401–67,500 of 175,825- K042183 — GLUCOSE TOLERANCE BEVERAGE
- K042268 — EBI CAS SPINE SPACER SYSTEM
- K042355 — SYNTHES (USA) LCP WRIST FUSION PLATES
- K042673 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K042833 — SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
- K041102 — IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
- K041775 — GE DATEX-OHMEDA ENGSTROM CARESTATION
- K042021 — EXACTECH EQUINOXE SHOULDER SYSTEM
- K042034 — NUVASIVE MAXCESS LIGHT GUIDE
- K042048 — GELATO PROPHYLAXIS PASTE
- K042075 — QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
- K042302 — ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE
- K042375 — SMK, CX, CXE, RCN
- K042376 — ACUMEN SHEATH, MODEL TTW7807
- K042435 — COOPER PROSTHETIC
- K042756 — ENDOREZ
- K042802 — H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168Q
- K041149 — GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE
- K041912 — SCB/VALLEYLAB FORCE FX INTERFACE UNIT
- K042300 — AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM
- K042380 — SILICONE BLOCK
- K042457 — URO PRO
- K040223 — POLYVAC INSTRUMENT DELIVERY SYSTEM
- K041136 — MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS
- K041486 — VASOSTASIS VASCULAR CLOSURE SYSTEM
- K041633 — GYRUS PLASMACISION LAPAROSCOPIC SPATULA
- K041703 — IPLAN!
- K041755 — CROMAX HIGH SPEED TURBINE HANDPIECE
- K042224 — RM3 RENAL PRESERVATION SYSTEM
- K042357 — IDI-MRSA ASSAY
- K042591 — SMARTMIX PRE-FILLED MIXING SYSTEM
- K042604 — VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS
- K042698 — UNFORS PATIENT SKIN DOSIMETER (PSD)
- K042728 — CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
- K042799 — QRS-CARD CARDIOLOGY SUITE
- K042821 — DIGITAL DETECTOR, MODEL GR17
- K033523 — COLLAGEN-ORC ANTIMICROBIAL MATRIX
- K041408 — POLYMEDCO OC AUTO MICRO 80 FOB TEST
- K042104 — AMERICAN BANTEX, MODEL MS 3
- K042209 — CONTROL PLASMA N AND CONTROL PLASMA P
- K042212 — IMPLANTMASTER
- K042305 — OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903
- K042444 — LITESTREAM 500E
- K042545 — HOVEROUND MPV-5 POWERCHAIR
- K042693 — IV ADMINISTRATION SET B400 SP
- K042779 — RADIOTHERAPY SOLUTION BASED ON CR
- K031832 — MEGA PURE CART
- K041068 — WEST NILE VIRUS IGG INDIRECT ELISA
- K041961 — SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
- K041963 — AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI
- K041988 — ARTHROTEK MENISCAL HYBRID DEVICE
- K042002 — SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
- K042071 — IBD-SCAN
- K042200 — MI PASTE
- K042369 — SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000
- K042383 — RSA-CMS
- K042484 — NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER
- K042658 — PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004
- K042669 — IONOFIL PLUS AC
- K042706 — OSSATURA DENTAL
- K042708 — ERA 3000 PACING SYSTEM ANALYZER
- K042759 — OPTIMA MX
- K042770 — MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
- K040839 — COMPLETE BLINK-N-CLEAN LENS DROPS
- K040866 — FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
- K041969 — AURORA DS
- K042031 — OPUS SPEEDSTITCH SUTURE DEVICE
- K042391 — KOLIBRI IMAGE GUIDED SURGERY SYSTEM
- K042445 — SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT
- K042465 — PS MEDICAL STRATA II VALVE
- K042492 — HAND STC, MODEL 60MM
- K042494 — VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
- K042539 — GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL
- K042587 — RETIC-CHEX FOR CELL-DYN
- K042646 — DYNACT
- K042674 — COLON CAR 1.2
- K042740 — ISC-1000 PENTAX CONFOCAL LASER SYSTEM
- K042741 — EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE
- K042781 — IPACS CARDIO
- K033943 — ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED
- K034017 — JEJE TEETHER
- K040485 — MAXAIR SURGICAL HELMET SYSTEM
- K041018 — DRG SOFTRELEASE
- K041272 — DYRACT CEM PLUS CEMENT
- K042165 — CUTERA TABLETOP AESTHETIC PRODUCT
- K042175 — HEPARINASE HR ACT CONTROL, MODEL 550-12
- K042206 — PURPLE/BLACK HEPARIN ASSAY CONTROL
- K042573 — KLS MARTIN DRILL-FREE MMF SCREW
- K042608 — TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110
- K042627 — EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
- K042800 — LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
- K031296 — LIQUI-HEME GLYCO A1C ASSAY
- K040760 — MODIFICATION TO URETERAL STENT
- K040875 — CAP-ONE, MODEL TG-920P
- K041506 — INTRAVASCULAR ACCESS INTRODUCER SHEATH
- K041718 — KELES FACEMASK
- K041740 — SILICONE COATED GUIDEWIRE
- K041918 — INTEGRATED PATIENT MONITORING SYSTEM
- K041934 — 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
- K041975 — VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501
Data sourced from openFDA. This site is unofficial and independent of the FDA.