FDA 510(k) clearances — page 721
clearances on record, most recent first.
Clearances — page 721
72,001–72,100 of 175,825- K031807 — SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS
- K031827 — ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX
- K031927 — GE DELTA SOFTWARE OPTION FOR MRI
- K023668 — JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR
- K024169 — MACROPORE OS RECONSTRUCTION
- K031033 — GIVEN DIAGNOSTIC SYSTEM
- K031392 — MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
- K031441 — URICHEMTRAK LIQUID ASSAYED URINE CONTROL
- K031445 — MAINLINE MAXIE HCG URINE PREGNANCY TEST
- K031685 — TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
- K031695 — HL168R
- K031734 — GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
- K031783 — SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005
- K031803 — DEPUY CERAMIC FEMORAL HEADS
- K031835 — HL888RA
- K024298 — ANTIMICROBIAL ALGINATE DRESSING
- K024323 — CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000
- K030559 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
- K031141 — ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE
- K031382 — MODIFICATION TO HERMES O.R. CONTROL CENTER
- K031540 — APEX ELECTRIC HANDPIECE SYSTEM
- K031754 — FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE
- K031884 — INTERFERENTIAL STIMULATOR, MODEL NETWAVE
- K031886 — SONOVIEW PRO BY MEDISON CO., LTD.
- K021979 — SMISSON STABILIZATION SYSTEM
- K023378 — ORIA CLARIS
- K030605 — RAPID IMF
- K030682 — CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3
- K030687 — K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
- K030744 — BLACKSTONE SURGICAL TITANIUM MESH
- K030838 — WARTNER PRO
- K030863 — EBV VCA-P18 IGG ELISA
- K031014 — HI-FLO THERME PNEU 45, WISAP #7083, 7083V
- K031023 — PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
- K031026 — ETI BIPOLAR HEMOSTATIC PROBE
- K031130 — YA MEI FIRST AID KIT
- K031188 — ORTHOMEND
- K031302 — SUSTAIN SPACER
- K031423 — EBI P148 SPINAL FIXATION SYSTEM
- K031486 — BLASTFREEZE AND BLASTTHAW
- K031521 — AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
- K031522 — SOLO-CARE PLUS MULTIPURPOSE SOLUTION
- K031538 — ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
- K031585 — U&I, OPTIMA, SPINAL SYSTEM
- K031655 — CD HORIZON SPINAL SYSTEM
- K031888 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K021328 — SMART BAG MO
- K023011 — OSMONICS SOLUTION DELIVERY SYSTEM
- K024000 — METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER
- K024181 — PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM
- K030581 — BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
- K030995 — MINILOK QUICKANCHOR PLUS
- K031027 — DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
- K031151 — TS3 TUBING SET
- K031414 — POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE
- K031591 — POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED
- K031622 — WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
- K031751 — RAPIDFIRE SELF DRILLING SCREWS
- K031766 — ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
- K014013 — H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM
- K023367 — DETECTAR, MODEL N123-MI
- K023817 — SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
- K030035 — IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
- K030708 — SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515
- K030990 — DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR
- K031010 — MIRACLE 98
- K031159 — CALIBRATING MATERIAL, CALIBRATING STANDARDS
- K031450 — QUANTA PLEX ENA PROFILE 6
- K031505 — RAPIDO CUT-AWAY GUIDING CATHETER
- K031644 — BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
- K031645 — EBI XFIX DFS SYSTEM
- K031682 — LIPOPROTEIN CALIBRATOR
- K031756 — ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
- K031781 — DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES
- K023355 — ASYRA
- K023430 — UF BRACHYTHERAPY STAND
- K023955 — BD VIPER INSTRUMENT
- K024270 — CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3
- K030578 — BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM
- K030875 — MODIFICATION TO COLORADO 2 SPINAL SYSTEM
- K030981 — ECLIPSE
- K031096 — MODIFICATION TO TRANSPORT INCUBATOR 185
- K031154 — SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
- K031200 — MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
- K031228 — SYNVITRO HYADASE
- K031393 — BAYER ADVIA CENTAUR CA 19-9 ASSAY
- K031460 — MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
- K031572 — ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
- K031595 — U & I AMERICA SPINAL HOOK SYSTEM
- K031680 — SPECTRAPULSE
- K031725 — SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
- K031773 — ENDO GATOR SYSTEM
- K031864 — NITREX NITINOL GUIDEWIRE
- K023333 — MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
- K030218 — PER, MODEL MEMO
- K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEM
- K031015 — EMBRYOGLUE
- K031038 — ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
- K031065 — SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5
- K031150 — HEMOBAG, MODEL HBBSD2000
Data sourced from openFDA. This site is unofficial and independent of the FDA.