FDA 510(k) clearances — page 891
clearances on record, most recent first.
Clearances — page 891
89,001–89,100 of 175,890- K982279 — VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200
- K982300 — TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A
- K982304 — DEVILBISS SUCTION UNIT
- K982330 — DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
- K982481 — A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR
- K982719 — THE BONE TIE
- K982842 — HUMAPEN AND HUMAPEN ERGO
- K983123 — POC ENT ENDOSCOPE - SINUSCOPE
- K983152 — OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS
- K974572 — GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820
- K981564 — AIR TECHNIQUES' AIRDENT II
- K981985 — ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209
- K982172 — CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL
- K982230 — LASETTE LASER SKIN PERFORATOR
- K982954 — FREE T4 MICROWELL EIA, MODEL #7019
- K983176 — ELECSYS MYOGLOBIN STAT ASSAY
- K974899 — GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
- K981069 — ULTRA-COVER PU-TRANSDUCER COVER
- K982244 — MAYFIELD ACCISS OPTICAL SYSTEM
- K982400 — STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT
- K982427 — TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C
- K982817 — EWC: ECG CABLE AND LEADWIRE SYSTEMS
- K982960 — MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
- K982962 — XENON LIGHT SOURCE, MODELS LS6180, LS6035
- K983134 — NBIL
- K972309 — JM-102 JAUNDICE METER
- K973721 — BIONECT HYDROGEL GAUZE PADS
- K973722 — BIONECT HYDROGEL FOAM
- K973724 — BIONECT HYDROGEL SPRAY
- K973725 — BIONECT CLEAR HYDROGEL
- K974226 — IMMUNODOT MONO-G TEST
- K974244 — IMMUNODOT MONO-M TEST
- K974685 — OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS
- K980398 — KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II
- K980798 — BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
- K980930 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
- K981260 — KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
- K981734 — VTEC-RPLA SEIKEN
- K982063 — ALM PRISMALIX (PRX) SURGICAL LIGHT
- K982073 — ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM
- K982221 — PREMIER AP
- K982259 — CHROMA ZONE COLOR STAIN
- K982271 — WAKO DIRECT LDL-C
- K982305 — SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT
- K982306 — POLYTUBE
- K982319 — CAREGRAPH
- K982403 — BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
- K982475 — SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL
- K982542 — STRYKER URETERAL ILLUMINATOR SYSTEM III
- K982546 — PHASER-2000
- K982553 — OSTEO COMPRESSION HIP SCREW SYSTEM
- K982565 — EASY TRANS TIP
- K982571 — KSEA FLIPPTACK
- K982800 — ECTON LYNX ULTRASOUND SYSTEM
- K982802 — BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K982869 — ASCENT SYSTEM
- K982922 — VACUTAINER BRAND BLOOD COLLECTION SYRINGE
- K982945 — DUAL PURPOSE CLOSED CATHETER
- K983017 — MODIFICATION TO SYSTEM 83 PLUS
- K983088 — INSTACINE D-2000
- K983114 — MAGNATEK80
- K983166 — ELECSYS CALCHECK MYOGLOBIN
- K981163 — DIAMEDIX IS-CMV IGG TEST SYSTEM
- K981682 — UPRO
- K982152 — QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152
- K982394 — PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
- K982767 — RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR
- K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
- K981297 — IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5
- K982176 — KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR
- K982182 — FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0
- K982215 — MANUAL RESUSCITATOR WITH ACE
- K982294 — XOMED SILICONE PRE-FORM BLOCKS
- K982496 — QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D
- K982846 — MTEK-1400
- K973448 — ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
- K981726 — PERCUSSIVETECH HF, MODEL 2001
- K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
- K982171 — HAMAMATSU PET SCANNER, MODEL SHR-22000
- K982179 — TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER
- K982405 — MTEK-1000
- K983003 — 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
- K973076 — EUROMEDICAL HAEMATURIA FOLEY CATHETER
- K974399 — BIO-OSS COLLAGEN
- K982105 — ORAL POTENTIAL METER (OPM)
- K982187 — FAST-CATH INTRA-CARDIAC INTRODUCER
- K982507 — MINI POLYURETHANE CATHETER
- K983133 — TBIL
- K970321 — BIO-OSS ANORGANIC BOVINE BONE
- K970700 — FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
- K981144 — CLEAN SOURCE I, MODEL CS1000
- K981563 — BIOPAK MEASUREMENT SYSTEM
- K981573 — UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE
- K981661 — HEMAPROMPT
- K982111 — VARIOUS DENTAL IMPLANTS
- K982135 — OSCILLOMATE EMS NIBP MONITOR MODEL 9001
- K982139 — BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM
- K982318 — SPECTRUM 800 CURING UNIT
- K982343 — ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3
- K982480 — PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.
Data sourced from openFDA. This site is unofficial and independent of the FDA.