FDA 510(k) clearances — page 947
clearances on record, most recent first.
Clearances — page 947
94,601–94,700 of 176,637- K971188 — SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS
- K971282 — ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
- K971293 — LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
- K971307 — AMSCO SURGICAL TABLE
- K971537 — PYLORISET EIA-G (68926)
- K971602 — ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
- K971665 — SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES
- K971676 — LIMITED REUSE ENDOSCOPIC BLADES
- K971682 — J-FX CERCLAGE SYSTEM
- K971692 — OSTEOPOWER SYSTEM AND ACCESSORIES
- K971716 — PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K971753 — DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500
- K971778 — OSTEO SMALL AND MINI BONE SCREWS
- K963732 — PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
- K964606 — THERATRON 780E
- K964673 — BAIR HUGGER MODEL 630 CARDIAC BLANKET
- K964716 — STA LIATEST CONTROL [N]+[P] KIT
- K964728 — STA-LIATEST D-DI TEST KIT
- K964969 — SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)
- K970012 — ESCORT LINK CENTRAL STATION MONITOR
- K970269 — CLINICATH IR PERIPHERALLY INSERTED CATHETER
- K970395 — QUIKSTRIP ONE STEP METHAMPHETAMINE
- K970543 — BOBCAT DX
- K971167 — NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
- K971368 — IDS4 IMAGE DISPLAY SYSTEM SERIES
- K971451 — WISE IMAGE MANAGEMENT SYSTEM
- K971491 — SYNERMED IR 200 CHEMISTRY ANALYZER
- K971899 — ENDO-SEAL
- K971995 — MEDIVISION SINOSCOPE
- K972070 — NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS
- K972076 — EPI-MAX EPISTAXIS CATHETER
- K972077 — EPI-STOP EPISTAXIS CATHETER
- K972136 — TV MONITOR (P12/17)
- K972246 — SPECTACLE FRAMES (NON-PRESCRIPTION)
- K943535 — MODEL ME 300 MUSCLE TESTER
- K963074 — HARMAC QUADPOLAR MAPPING PACING CATHETER
- K964757 — CONTIDRAIN CATHETER
- K964923 — CODMAN LUMBAR DRAINAGE CATHETER KIT
- K970285 — AESUCLAP SOCON SPINAL SYSTEM
- K970879 — CARDIOVIT CS-200
- K971139 — BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
- K971144 — MULTITAK SS SUTURE SYSTEM
- K971153 — SPLITSCREEN (ME-975)
- K971154 — MULTIPICS(ME-977)
- K971331 — SATELLITE
- K971541 — VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON
- K971596 — EMIT II OPIATES 300/2000 ASSAY
- K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
- K971679 — I-SCOPE OPHTHALMIC ENDOSCOPE
- K971841 — BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
- K962811 — SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION
- K963546 — SMF TITANIUM (TI) ALLOY BONE SCREWS
- K964595 — OPUS PSA TEST SYSTEM
- K964826 — POWDER - FREE LATEX EXAMINATION GLOVES APPLICATION
- K964974 — MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE
- K965027 — VENTED I.V. SET
- K965192 — THAIRAPY VEST SYSTEM
- K970015 — ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES
- K970102 — FILTER
- K970222 — LOW PROTEIN LATEX EXAMINATION GLOVES
- K970542 — MASTER NEB II
- K970551 — QUANTA LITE B2GPI IGG
- K970612 — SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
- K970855 — CLAVE CONNECTOR
- K970882 — ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
- K970918 — BROWNE STEAM INDICATOR
- K971126 — HYDROCOLLOID WOUND DRESSINGS
- K971129 — OXYPURE PORTABLE OXYGEN GENERATOR
- K971159 — SURGICAL DRAPES
- K971193 — LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM
- K971453 — ORTHOTEC K-CAP SYSTEM
- K971482 — DEGANIA SILICONE SIL-K
- K971483 — SECURE-WRAP (TM) STERILIZATION WRAP
- K971639 — PLUSTRON ION TOOTHBRUSH SYSTEM
- K971644 — CEBE
- K971685 — IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM
- K971711 — SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR
- K971780 — THYROTROPIN(TSH) ELISA
- K971898 — PERMALUTE, TRY-IN PASTE
- K971907 — CALCIUM REAGENT
- K971921 — PROLACTIN (PRL) HORMONE MICROPLATE ELISA
- K971987 — SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR
- K972014 — SUNGLASSES (NON-PRESCRIPTION)
- K972047 — KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE
- K972073 — TOTAL BILIRUBIN REAGENT
- K972133 — VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
- K972174 — LYPHOCHEK REMEDI CONTROL
- K972194 — RIVIERA SUNGLASS4ES
- K972214 — ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
- K972232 — ABBOTT AXSYM FOLATE
- K970127 — EDOSSEOUS DENTAL IMPLANT
- K970752 — SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM
- K971083 — ARTHROSCOPE
- K971149 — SVL-9130 DEFIBRILLATION ELECTRODE
- K971075 — PRIMED PRIME-PLUS COTTON GAUZE SPONGES
- K940954 — SYNAPTIC 3000
- K963932 — PRELOADED SOFT TISSUE ANCHOR
- K964206 — NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2
- K964688 — LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT
- K964947 — PHOTON RADIOSURGERY SYSTEM (PRS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.