FDA 510(k) clearances — page 841
clearances on record, most recent first.
Clearances — page 841
84,001–84,100 of 176,637- K000290 — LAZERSMILE, LAZERWHITE
- K000346 — EZ CONNECT
- K000366 — FIXATION STYLETS, MODELS 335-287 AND 335-288
- K000373 — 939UDX URINE PATHOLOGY SYSTEM
- K000411 — CHILI VIDEO, CHILI VIDEOPRO
- K000437 — INTERVENTIONAL BODY COIL
- K000460 — URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
- K000464 — URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
- K000467 — URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
- K000486 — ABC CERVICAL PLATING SYSTEM
- K000494 — SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
- K000558 — SYNTHES (USA) WRIST FUSION PLATES (WFP)
- K000826 — PRODIGY LATERAL VIEW SOFTWARE
- K000864 — INTRASTENT DOUBLESTRUT XS STENT
- K000898 — EEG WITH VIDEO, MODEL EX-NW
- K000911 — MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057
- K000971 — PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
- K001033 — AGILITY STEERABLE GUIDEWIRE
- K001037 — MODIFICATION TO EBI SPINELINK SYSTEM
- K991519 — AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
- K993092 — SONADA ULTRASOUND SYSTEM
- K993489 — CRYSTAL CUSTOM TINTED SOFT CONTACT LENS
- K993503 — HAIDER-UCR SPINAL SYSTEM
- K993545 — TENAX WHITE POST
- K993787 — APPRAISE-CARDIO SAMPLE COLLECTION KIT
- K000112 — ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
- K000117 — AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
- K000147 — CTC DVT-1 CALF GARMENT, MODEL DVT-1
- K000168 — CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
- K000199 — CORTEK MINI LAPAROSCOPE
- K000206 — PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
- K000526 — HARDYDISK, CEPHALOTHIN 30MCG
- K000570 — BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA
- K000646 — DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
- K000661 — RANDOX PREALBUMIN
- K000810 — QUALITROL LIPID CONTROL, LEVELS 1 AND 2
- K000824 — PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
- K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC
- K992664 — TFX MEDICAL STYLET CATHETER
- K992942 — LEMAITRE OCCLUSION CATHETER
- K993608 — DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)
- K993695 — LIGA-LOOP SUTURE APPLICATOR
- K994027 — ACTIVATOR PASTE
- K994164 — ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
- K994221 — BAYER PSA ASSAY
- K994240 — EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133
- K000097 — GSI 2000 MIDDLE EAR ANALYZER
- K000098 — SOFTLINE SPRING CLIP
- K000105 — MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),
- K000125 — JET PORT PLUS CATHETER SYSTEM
- K000127 — KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
- K000275 — DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA
- K000314 — INCENTIVE SPIROMETER
- K000337 — MTP DISPOSABLE TROCAR VALVES
- K000390 — VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- K000391 — VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K000426 — VIP- VARIABLE INTENSITY POLYMERIZER
- K000555 — TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O
- K000584 — POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K000670 — NITRILE EXAM GLOVE, POWDER FREE, BLUE
- K000688 — UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES
- K000740 — ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S
- K000793 — 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
- K001008 — TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921
- K991677 — REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)
- K992553 — IQ CHAMBERS
- K993116 — A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER
- K994099 — VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
- K000148 — RGP MULTI-PURPOSE SOLUTION ID 100136
- K000198 — CORTEK ARTHROSCOPE
- K000221 — SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
- K000345 — MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES
- K000350 — SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST
- K000415 — OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM
- K000441 — BODYGUARD
- K000471 — FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
- K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
- K000777 — SAMPLOK
- K000878 — HONIGUM
- K972610 — POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C
- K990830 — MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS
- K000135 — PRO.DUCT CATHETER, MODEL CTH03
- K000151 — PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
- K000192 — E3 MICROPROB SERIES OF LASERS AND ACCESSORIES
- K000194 — DIGITAL INFLECTION RIGIDOMETER (DIR)
- K000321 — HEMISPHERE MODULAR CUP SYSTEM
- K000410 — SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
- K000652 — BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K000794 — MODIFICATION TO MARSPO2, MODEL 2001
- K000843 — MODIFICATION TO JMS APHERESIS NEEDLE
- K000845 — MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
- K000854 — VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER
- K000979 — REDI-SCREEN
- K991458 — MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254
- K993272 — PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
- K993305 — TRANSLUMINAL BALLOON DILATATION CATHETER
- K993448 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
- K993616 — CARDIO-CARD INTERPRETATION SYSTEM I
- K993867 — BAYER ADVIA IMS SYSTEM
- K994062 — HMS NEUROMUSCULAR STIMULATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.