FDA 510(k) clearances — page 389
clearances on record, most recent first.
Clearances — page 389
38,801–38,900 of 176,542- K132653 — NEOPLATE SPINE ANTERIOR FIXATION SYSTEM
- K133046 — OMNIPORE CUSTOMIZED SURGICAL IMPLANTS
- K133153 — SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
- K133620 — CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM
- K133700 — ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS
- K133912 — ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO
- K140255 — STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA)
- K140408 — SALVATION OSTEOPENIC SCREW
- K140591 — BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR
- K140604 — MULTIFIX S KNOTLESS FIXATION SYSTEM
- K140724 — MSP METATARSAL SHORTENING SYSTEM
- K141010 — M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM
- DEN140004 — QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
- K130080 — EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL
- K132899 — EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD)
- K133148 — BIOMARC COAXIAL NEEDLE
- K133206 — Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM
- K133272 — VERSACUT + TISSUE MORCELLATOR
- K133317 — PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
- K140056 — DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A
- K140060 — DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
- K140198 — IMDX HSV-1/2 FOR ABBOTT M2000
- K140343 — AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP
- K140395 — VITREA IMAGE DENOISING SOFTWARE
- K140568 — CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT
- K140622 — DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
- K140970 — ONE-PIECE PEEK FUSION IMPLANT
- K131176 — ROSS RU SKIN DISCONTINUITIES
- K131531 — TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE
- K132529 — GALLIEON-1 MEDICAL LASER
- K132686 — AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE
- K133042 — ENDOCEM ZR
- K133054 — ENDOSEAL
- K133378 — ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
- K133718 — ZERONA
- K140124 — S9 ELOUERA
- K140419 — SUPERCATH5
- K140606 — 1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL
- DEN120016 — DEKA ARM SYSTEM
- DEN130015 — PIXEL 3 SYSTEM
- K130775 — DUET SYSTEM
- K131557 — RITTER IMPLANT SYSTEM
- K131711 — YZ3 PORTABLE SLIT LAMP
- K131790 — A9800 ANESTHESIA WORKSTATION
- K133203 — SINGLE-SITE PORT
- K133251 — BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
- K133565 — LEKSELL GAMMA KNIFE PERFEXION
- K134055 — ADX4000W
- K140122 — CANDELA GENTLEMAX FAMILY OF LASER SYSTEM
- K140354 — ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
- K130067 — MRNA APPLIANCE
- K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
- K133200 — STALIF C(R)
- K133722 — ASTHMA MONITOR AM3
- K133731 — NOBELACTIVE WIDE PLATFORM (WP)
- K140206 — SCINTILLATION GAMMA CAMERA
- K140252 — 16 CH MULTIPURPOSE COIL VARIETY
- K140269 — HERMES MEDICAL IMAGING SUITE V5.4
- K140404 — ELECSYS CK-MB STAT IMMUNOASSAY
- K140607 — AAP LOQTEC(R) OLECRANON PLATE
- K140755 — ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS
- K141081 — FILTEK BULK FILL POSTERIOR RESTROATIVE
- K132397 — GORE BIO-A WOUND MATRIX
- K132475 — FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
- K132870 — Origio Gas Line Filter
- K133690 — TRUE SPINAL FUSSION SYSTEM
- K133801 — BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
- K140070 — LUXER SHADED ZIRCONIA
- K140238 — EXCELLA III-D SPINAL DEFORMITY SYSTEM
- K140311 — CARESITE LUER ACCESS DEVICE
- K140814 — EVOS MINI-FRAGMENT PLATING SYSTEM
- K140941 — PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
- K122656 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
- K131468 — DENRACLE DENTAL ABUTMENT
- K140111 — BD MAX(TM) ENTERIC BACTERIAL PANEL; BD MAX(TM) INSTRUMENT
- K140904 — RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6
- K140916 — LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
- K133204 — AIRVIEW MINI OWIE DICK TEST PACK
- K140066 — INFILL CERVICAL
- K140887 — COBAS CT/NG V2.0 TEST
- K140899 — HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM
- K132004 — NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE
- K132038 — ACCUTORR 7 VITAL SIGNS MONITOR
- K132167 — I-CHROMA IFOB WITH I-CHROMA READER
- K132476 — SHARPS CONTAINER
- K133051 — PULMONE MINIBOX PFT TM
- K133064 — MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31
- K133530 — NUVASIVE EMG ENDOTRACHEAL TUBE
- K133616 — MATRIXRIB FIXATION SYSTEM
- K133934 — MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER)
- K134017 — GIGALASER
- K140272 — SWIFT-LOCK ANCHOR
- K140407 — FILMARRAY GASTROINTESTINAL (GI) PANEL
- K140638 — PROPELLER SYSTEM - MODEL 2
- K140856 — BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
- K122817 — SILVERLON ISLAND WOUND DRESSING
- K131866 — SUSTAIN
- K131920 — STABILIZATION SCREW
- K132027 — OEC 9800 PLUS
- K132637 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.