FDA 510(k) clearances — page 730
clearances on record, most recent first.
Clearances — page 730
72,901–73,000 of 176,637- K031595 — U & I AMERICA SPINAL HOOK SYSTEM
- K031680 — SPECTRAPULSE
- K031725 — SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
- K031773 — ENDO GATOR SYSTEM
- K031864 — NITREX NITINOL GUIDEWIRE
- K023333 — MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
- K030218 — PER, MODEL MEMO
- K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEM
- K031015 — EMBRYOGLUE
- K031038 — ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
- K031065 — SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5
- K031150 — HEMOBAG, MODEL HBBSD2000
- K031346 — JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
- K031350 — 3TP SOFTWARE OPTION
- K031556 — VIVATHERM THEMPERATURE MEASUREMENT SYSTEM
- K031635 — DEPUY ACROMED VBR SYSTEM
- K024189 — NLITE SYSTEM, MODEL#: A00-1025/A00-1033
- K024243 — REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406
- K024259 — PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300
- K030330 — CTXA HIP EXTENDED REFERENCE DATA
- K030944 — EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
- K030963 — TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
- K031095 — SENSE BODY COIL
- K031198 — SCANX 10
- K031248 — CONSULTIVA REPORT STATION, MODEL RS-1
- K031311 — INTEGRADWEB BY DYNAMIC IMAGING, INC.
- K031391 — HF MODULE WITH TRANSDUCERS
- K031468 — TEMPORARY TITANIUM ANEURYSM CLIP
- K031606 — ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
- K031653 — DATEX-OHMEDA HMEF 750
- K031675 — SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
- K031825 — C.CAM
- K031871 — AUTOBONE
- K031872 — ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]
- K023036 — CARE ETS
- K023815 — C-1805M
- K023896 — C-1890
- K024093 — MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS
- K024372 — CP MEDICAL BONE WAX
- K030174 — GENICON LAPAROSCOPES
- K030401 — DISPOSABLE M2-PE MICROKERATOME BLADES
- K030897 — SKINSTATION
- K030900 — INION OTPS BIODEGRADABLE FIXATON SYSTEM
- K030916 — UFI GEL HARD C
- K030946 — HEMCON BANDAGE OTC; HEMCON CATH/AID
- K031029 — ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
- K031041 — FLUENCY TRACHEOBRONCHIAL STENT GRAFT
- K031164 — PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
- K031177 — DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
- K031353 — SOLUTION FACE MASKS
- K031571 — EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
- K031626 — ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
- K023028 — DEMETECH NYLON NONABSORBABLE SUTURE
- K023030 — DEMETECH POLYESTER NONABSORBABLE SUTURE
- K023335 — QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
- K023591 — ULTRA HIGH PRESSURE INJECTOR LINES
- K023898 — GYNE IDEAS MINITAPE RP DEVICE
- K024057 — CURAD SCAR THERAPY
- K030654 — VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
- K030883 — OMNILUX BLUE
- K031005 — LUMEND FRONTRUNNER GW CTO CATHETER
- K031231 — LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS
- K031233 — ANDIODYNAMICS, INC. ELVS PROCEDURE KIT
- K031443 — LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS
- K031452 — ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
- K031510 — NIM-SPINE
- K031605 — INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
- K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
- K023726 — TENS PRO 900
- K030099 — BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
- K030528 — ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)
- K030531 — MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
- K030891 — SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK
- K030948 — VMATE MODEL VMM1000
- K031271 — ONE-STEP PREGNANCY TEST
- K031326 — IMAGINE REFLEX
- K031384 — MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G
- K031409 — URINARY CATHETERS
- K031535 — PHILIPS EASYDIAGNOST ELEVA
- K031696 — LORENZE EXTERNAL MANDIBULAR DISTRACTOR
- K031705 — SKYLIGHT IMAGING SYSTEM
- DEN030002 — ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
- K030020 — HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER
- K030950 — VIDAS TROPONIN I (TNI), MODEL 30 445
- K031048 — CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
- K031101 — RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
- K031197 — MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K031583 — MODIFICATION TO IVS INTRODUCER SET, MODEL 1003
- K023881 — PROFILE 1064 LASER SYSTEM
- K030211 — RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
- K030844 — FINAL VARNISH LC
- K030887 — LEKTROGEL, MODEL LK3001
- K031021 — CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
- K031052 — CARESTART HCG ONE-STEP PREGNANCY TEST
- K031058 — CORD STICK MULTIPLE DRAW SYSTEM
- K031205 — PASCO MIC AND MIC/ID PANELS
- K031533 — VANTAGE ANTERIOR FIXATION SYSTEM
- K023559 — FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
- K023670 — SINGLE USE ORAL MASK, MODEL HC455A
- K030197 — BLACKSTONE POSTERIOR CERVICAL SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.