FDA 510(k) clearances — page 797
clearances on record, most recent first.
Clearances — page 797
79,601–79,700 of 175,825- K011028 — SCREW-VENT DENTAL IMPLANT SYSTEM
- K002948 — K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
- K003828 — VASO PRESS DVT FOOT GARMENT #VP 520
- K010162 — EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
- K010485 — VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER
- K010516 — ADVANTA SST GRAFT (>_6MM)
- K010517 — ADVANTA SST GRAFT (<6MM)
- K010644 — CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
- K010672 — MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
- K010689 — MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM
- K010690 — SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR
- K010710 — SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES
- K010958 — FISTULOK FISTULA NEEDLE PROTECTION
- K010978 — TINA-QUANT ALPHA-1 ANTITRYPSIN
- K011169 — HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3
- K011188 — GE LOGIQ 9, MODEL 2188900-X
- K011219 — ASCENT KNEE SYSTEM
- K011233 — MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
- K011385 — HARDKYDISK NEOMYCIN, 30 MCG
- K003486 — STEREOTACTIC FRAME BASED SYSTEM
- K010101 — GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM
- K010177 — VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
- K010464 — RADCALC, MODEL V.4.0
- K010551 — EBI DYNAFIX VS OSTEOTOMY SYSTEM
- K010620 — ENDOSCOPIC STAPLE REMOVAL INSTRUMENT
- K011064 — CLASSIC CEM
- K011167 — XSE
- K011198 — SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL
- K011300 — EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
- K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
- K002037 — LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
- K003084 — CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
- K003086 — CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
- K003609 — N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
- K003707 — CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A
- K003712 — MODIFICATION TO MALE TO MALE LUER ADAPTER
- K003732 — BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
- K003880 — CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)
- K010448 — HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
- K010466 — TETHER ACFS
- K010510 — BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1
- K010587 — ACTIVEECG
- K010659 — SEA-LONG MEDICAL TREATMENT HOOD
- K010730 — MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
- K010747 — OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830
- K010881 — UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K011079 — K-ASSAY HS-CRP CONTROLS
- K011154 — ELIPAR FREELIGHT
- K011160 — E-Z EM PERCUPUMP 2001 CT INJECTOR
- K011182 — MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
- K011213 — MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
- K011217 — CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
- K011218 — ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
- K011286 — POWDER-FREE NITRILE EXAM GLOVE, BLUE
- K011306 — EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
- K001694 — GUIDANT RETRIEVER DEVICE
- K001699 — RUBICON PROTHROMBIN TIME MONITORING SYSTEM
- K010565 — DYNATRON STS
- K010566 — COLLEAGUE VOLUMETRIC INFUSION PUMP
- K010855 — RANDOX IGE
- K010917 — POWER TILT AND RECLINE SYSTEM
- K010948 — DYNATRON STS RX
- K011038 — TAPER-LOCK DENTAL IMPLANT SYSTEM
- K011149 — DISPOSABLE BENDING CANNULA PR-233Q
- K011151 — EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
- K011161 — MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
- K011268 — BREEZY WHEELCHAIR, MODEL 300
- K011289 — EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
- K011314 — OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
- K011315 — SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5
- K003122 — SMARTFLOW, MODEL SFIP 2000
- K004012 — IMPRA CARBOFLO EPTFE VASCULAR GRAFTS
- K010197 — EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
- K010436 — TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011
- K010457 — ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
- K010460 — LIFELINES TRACKIT
- K010465 — DENSTAT
- K010519 — MAGNUM FLOW IRRIGATION SYSTEM
- K010673 — ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
- K011107 — MODIFICATION TO SOLO
- K011236 — MODIFICATION TO IMPLANTABLE CLIP
- K011380 — MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
- K002639 — BIOKNOTLESS ANCHOR
- K003020 — CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER
- K003480 — BIOFIND
- K003504 — RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
- K004018 — SKINGARD POLYCOAT GLOVE
- K010395 — E-POWER
- K010470 — R & D 4K RETIC
- K010552 — CG-900P FETAL/MATERNAL MONITOR
- K010803 — POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
- K011006 — AMYSEAT TILT/RECLINE SEATING
- K011227 — REGAL MOTOTRIZED 3 WHEELED VEHICLE
- K003400 — CRP HS TEST SYSTEM
- K003754 — IMMUNETICS C6 LYME ELISA KIT
- K010291 — ITI DENTAL IMPLANT SYSTEM
- K010458 — THE MAESTRO SYSTEM
- K010696 — BECKMAN COULTER DNASE B CALIBRATOR
- K010794 — BRIDGE III RECEIVER
- K010816 — DENTO-PREP PARTICLE MICROBLASTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.