FDA 510(k) clearances — page 841
clearances on record, most recent first.
Clearances — page 841
84,001–84,100 of 175,890- K000079 — NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
- K000131 — QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
- K000207 — POROCOAT PRODIGY HIP PROSTHESIS
- K991412 — VITALOGRAPH MICRO
- K991580 — ILM ENDOTRACHEAL TUBE
- K992012 — WILTSE SYSTEM
- K992525 — ACUMED MODULAR SHOULDER SYSTEM
- K992805 — ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)
- K993762 — I.CO.S SCREW
- K993785 — ULTRACLIP TISSUE MARKER
- K993834 — SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C
- K993898 — KAC-63 KNEE ARRAY COIL
- K993943 — ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA
- K993997 — POLYPROPYLENE
- K993998 — NYLON
- K993999 — SILK
- K994000 — POLYESTER
- K994002 — PLAIN/CHROMIC CATGUT
- K994007 — MALLORY/HEAD SMOOTH FEMORAL COMPONENT
- K994090 — KARL STORZ AUTOCLAVABLE CAMERA HEAD
- K994117 — MR ENHANCER
- K994160 — COALESCENT SURGICAL SUTURED-CLIP
- K994210 — INTURIS SUITE
- K994211 — ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
- K994294 — DIMENSION TRNF FLEX REAGENT CARTRIDGE
- K994315 — CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
- K994383 — DOGBONE ACFS
- K994438 — BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
- K000020 — MODIFICATION TO ISOBAR SPINAL SYSTEM
- K000083 — EBI XFIX DFS RAIL SYSTEM
- K000089 — SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
- K000120 — PRO-TORQ
- K000172 — DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
- K990403 — TED 200T7 OXYGEN MONITOR
- K992652 — SD-730 IF-SDS, PERFECT PULSE IF-SDS
- K992804 — T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ARD-TG424, ARD-TS525, ARD-TJAZZY, ARD-TLANCER
- K992828 — E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER
- K993051 — VERSALET 7700 CARE CENTER, MODEL # 7700
- K993383 — HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B
- K993745 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
- K993810 — CD HORIZON SPINAL SYSTEM
- K994006 — AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)
- K994024 — EXTENDED STRAIGHT ATTACHMENT
- K994127 — GLORY
- K994136 — POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
- K994168 — SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR
- K994169 — SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR
- K994227 — ADVANTAGE HCG TEST (URINE/SERUM)
- K994256 — SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823
- K994268 — ARABESK TOP
- K994338 — AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
- K994415 — MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS
- K994416 — POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
- K991379 — QUINN'S SPERM WASHING MEDIUM
- K991393 — HYALURONIDASE, 80 U/ML
- K992322 — SNAP MODEL 5
- K992787 — EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR
- K993580 — SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
- K993742 — SUPER TISSUE
- K993750 — PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO
- K993751 — COROMETRICS MODEL 173 FETAL MONITOR
- K993779 — SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED
- K993781 — SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED
- K993782 — SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9)
- K993786 — RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY
- K993917 — TOKUYAMA ONE-UP-BOND F
- K994261 — ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT
- K000044 — ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS
- K992708 — IONTOPATCH
- K993085 — AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
- K993547 — BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB
- K993549 — BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR
- K993553 — GTI-FVIII INHIBITOR ASSAY
- K993724 — HSV-2 ELISA IGG, MODEL EL0920G
- K993828 — CERALAS D10 810NM DIODE LASER
- K993878 — JE 2000
- K993904 — INTRASTENT DOUBLESTRUT LD
- K993910 — TAC' PIN
- K993911 — CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50
- K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
- K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
- K994035 — IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
- K994046 — HARDYDISK CEFACLOR 30MCG
- K994148 — 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
- K994346 — ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
- K000048 — SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
- K990227 — ULTRASHAPER KERATOME
- K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING
- K992648 — ROTARY MASTER
- K993840 — BARD UROFORCE BALLOON DILATION CATHETER
- K993857 — THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR
- K993906 — NANMA NON-ADJUSTABLE CONSTRICTION RING
- K993908 — NANMA AJUSTABLE CONSTRICTION RING
- K994042 — SHARP 9000 PHASED ARRAY BRAIN COIL
- K994224 — PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL
- K994246 — OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
- K994354 — POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K000065 — CAMLOG CYLINDER IMPLANT SYSTEM
- K000099 — CAMLOG SCREW IMPLANT SYSTEM
- K000100 — CAMLOG ROOTFORM IMPLANT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.