FDA 510(k) clearances — page 820
clearances on record, most recent first.
Clearances — page 820
81,901–82,000 of 175,825- K002121 — TOTAL PSA MICROTITER ELISA
- K002195 — FORAMATRON V, MODEL D680
- K002312 — PROTON VISION 7.0
- K002313 — COMPLEXED PSA MICROTITER ELISA
- K002319 — PURILENS SALINE SOLUTION
- K002400 — MODIFICATION OF ACL ADVANCE
- K002404 — MICRO-MAX, MODEL 319
- K002533 — TCD 100M, PWD13 TRANSDUCER
- K002535 — LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513
- K002536 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)
- K002539 — OBC-096 BREAST ARRAY COIL
- K984570 — MINOLTA PULSOX-3/MINOLTA PULSOX-3I
- K994283 — MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
- K001731 — AVID-NIT LOSS OF RESISTANCE SYRINGE
- K001903 — NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
- K001922 — DEPUY NEUFLEX PIP FINGER
- K001938 — VECTOR TARGETING SYSTEM
- K002138 — PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
- K002276 — PSI SKULL CLAMP
- K002378 — MODULAR PORP AND TORP MODEL TBD
- K002401 — CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
- K002464 — SMITH & NEPHEW OFF-CENTERED PORP
- K001648 — INTRASTENT DOUBLESTRUT PARAMOUNT
- K001899 — IMPROVED TRY-IN GEL
- K001960 — RIGID GAS PERMEABLE CONTACT LENS
- K991495 — FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS
- K000983 — CERAMIX PORCELAIN SYSTEM
- K002351 — FLUOROTEX II SURGICAL MESH
- K000354 — C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570
- K000356 — C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580
- K000808 — RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
- K000811 — NLITE SYSTEM, SLS MODEL NUMBER A00-1025
- K001681 — POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
- K001743 — ULTIMA SMARTBELT, MODEL 0560
- K001909 — PLAINSENSE WHEELCHAIR
- K001923 — REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800
- K001991 — TITAN POROCOAT HIP PROSTHESIS
- K002020 — LACTOSORB MENISCAL SCREW
- K002070 — BIOLOK SCREW
- K002100 — XIMX SYSTEM
- K002129 — FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN
- K002157 — RANGER II M6, MODEL IN-888WNL
- K002167 — KARMAN WHEELCHAIR
- K002200 — CAPELLA
- K002202 — KARMAN WHEELCHAIR
- K002260 — SPINA SYSTEM
- K002271 — 2.4MM CORTEX SCREW, SELF-TAPPING
- K002277 — FRESENIUS OPTIFLUX 200NR
- K002287 — WIZAIR COMPRESSION SYSTEM
- K002317 — MODEL 9000 BARIATRIC WHEELCHAIR
- K002365 — DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
- K002388 — EHC500 DESKTOP PATIENT STATION, MODEL EHC500
- K002491 — COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS
- K992831 — AERONEB II, MODEL APN 200
- K994198 — HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
- K000158 — VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
- K000401 — VAPOTHERM, MODEL 2000I
- K000718 — CHROMOSTREAK
- K001560 — ODONTOSURGE 3
- K001633 — LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000
- K001636 — C-REACTIVE PROTEIN ANTISERUM KIT
- K001666 — MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
- K001720 — SYNTHES SACRAL BAR SYSTEM
- K001759 — HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ
- K001847 — ANTERIOR CERVICAL PLATE SYSTEM
- K002021 — HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE
- K002206 — HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
- K002298 — SUPER 1
- K002324 — MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
- K002435 — MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
- K000355 — 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR
- K000859 — OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
- K001814 — DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES
- K001943 — CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
- K002240 — RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0
- K002434 — PALM PUMP
- K993950 — CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999
- K000475 — BRACHYSEED
- K000969 — MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1
- K001598 — BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION
- K001740 — KSEA MONOPOLAR VAPORIZATION ELECTRODES
- K001881 — IMPROVED ENLIGHT LV
- K001935 — ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565
- K002065 — PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR
- K002148 — ELECSYS HCG TEST SYSTEM
- K002174 — DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3
- K002223 — EPIC SPO2 FINGER SENSOR, MODEL E412-20
- K002238 — CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
- K002340 — VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW
- K001392 — GLYCOSAL HBA1C TEST
- K001411 — WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056
- K001462 — CARESIDE HEMOGLOBIN
- K001556 — HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
- K001683 — SYSMEX R-500
- K001875 — DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
- K001981 — DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
- K002120 — LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
- K000209 — DOSE 1
- K001325 — FLO ASSISTANT, MODEL 4-250-00
- K001589 — CANDELA DYNAMIC COOLING DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.