FDA 510(k) clearances — page 1085
clearances on record, most recent first.
Clearances — page 1085
108,401–108,500 of 175,890- K940207 — TITANIUM ALLOY BONE SCREWS
- K940429 — ORTHO TECH CRYOLOGIC SYSTEM
- K940488 — CHEN-HERSIN SUNGLASSES
- K940516 — AUTO REFF-30
- K940625 — CHEN SHUENG ENTERPRISE CO.
- K940626 — CLEVER OPTICAL INDUSTRIES LTD
- K940627 — WENZHOU IMPORT AND EXPORT CORP
- K940628 — JIHN MEI OPTICAL CO.
- K940629 — YEOU NAN SUNGLASSES CO
- K940858 — THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)
- K940868 — CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION
- K940893 — A-DEC RADIUS 2122/2132
- K940924 — SUNGLASSES
- K941047 — WESTERN TRADING CO
- K941053 — NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES
- K941359 — GIP/MEDI-GLOBE BIOPSY FORCEPS
- K941414 — EYECOTECH CORP
- K941431 — BONE GRAFT DELIVERY SYRINGES
- K941441 — NON-PRESCRIPTION SUNGLASSES
- K941538 — SUNGLASSES
- K941555 — SUNGLASSES/VARIOUS COLLECTIONS
- K941847 — 5/8 POROCOAT AML HIP POROCOAT POROUS COATING
- K941942 — SOLUTION HIP
- K942023 — INFUSION PUMP, MODEL NO. UDP-5
- K942086 — PATIENT EXAMINATION GLOVE
- K942234 — VISITEC PRECISE-POINT
- K942348 — PAUL SMITH SPECTACLES LTD. BY OLIVER PEOPLES, INC.
- K942463 — FRAME, SPECTACLE
- K942500 — SUNGLASSES TOKYO BAY
- K942588 — NON-PRESCRIPTION SUNGLASSES
- K942630 — WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE
- K942652 — SCHOOL MASCOT EYEWEAR
- K931560 — CARDIAC CATHETERIZATION TRAY
- K933284 — AS/3 TM NETWORK
- K934051 — BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)
- K935146 — DISPOSABLE STETHOSCOPE HEAD COVER
- K935189 — E-Z DERM BIOSYNTHETIC WOUND DRESSING
- K936099 — NEUROLOGICAL LEAD ACCESSORIES
- K940409 — M-K HYDROGEL DRESSING
- K941058 — PROCATH PACING THRESHOLD CABLE
- K941239 — AESCULAP NEUROENDOSCOPE
- K942798 — MPM HYDROGEL
- K942815 — HYDROSKIN WOUND DRESSING
- K920579 — LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE
- K930071 — SARGON CYLINDRO-BLADE IMPLANT
- K931456 — SURGICAL DRAPE AND GOWN TRAY
- K933318 — COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B
- K933803 — DISPOSABLE TAB ELECTRODE
- K933906 — CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION
- K940686 — ELECTRONIC THERMOMETERS
- K941910 — SUNGLASSES
- K941954 — NON-FOGGING DENTAL MIRROR
- K942022 — FACE-IT SHIELD
- K942313 — GUARDIAN GLOVE
- K942315 — NAVARRE PERCUTANEOUS ACCESS SET
- K942343 — LASEAWAY Q-SWITCHED RUBY LASER SYSTEM
- K942418 — PLAYTEX TAMPONS MODEL 13794
- K942521 — CONSERVA POST SYSTEM
- K942583 — PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT
- K942678 — LIFTING DISTENTION BALLOON SYSTEM
- K942724 — EXTERNAL NASAL SPLINT
- K942758 — HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE
- K942767 — ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN
- K942915 — ELECTROSURGICAL LAPAROSCOPIC INSTRUMENT
- K922455 — EVERT-O-CATH CATHETER
- K931720 — LUNDIA ALPHA 700 HEMODIALYZER
- K932982 — SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
- K932983 — COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
- K932984 — UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI
- K934333 — 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE
- K935659 — BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST
- K935719 — DAIL A HEARING SCREENING TEST
- K941151 — STRATOFUSE PCA II INFUSER
- K941249 — SPECIMEN REMOVAL DEVICE
- K941836 — UNILENS 38 SOFT ASPHERIC CONTACT LENS
- K942010 — VASCU-GUARD
- K942205 — ZEBRA UROLOGICAL GUIDEWIRE
- K942372 — SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS
- K942491 — ORIGIN BALLOON RETRACTOR
- K942639 — BIOPSY NEEDLE AND HOUSING
- K942641 — SURGIN IRRIGATION PUMP
- K922106 — ALICE
- K930047 — DSL IGFBP-3 RIA (DSL 6700)
- K932093 — AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S
- K932892 — PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS
- K934293 — BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT
- K934457 — STABILITY HIP STEM WITH POROCOAT
- K934498 — DOA LIQUID DRUGS OF ABUSE CONTROLS
- K936051 — OMNI-CENTRAL STATION MONITOR
- K936112 — STREP B OIA
- K940567 — MODEL#1550 MARSONA(R) TINNITUS MASKER
- K940647 — ORBSCAN(TM) KERATOMETER
- K940935 — URINE CALIBRATOR
- K941355 — PREGNANCY CHECK
- K941428 — EXACTA PERCUTANEOUS INTRODUCER SHEATH
- K941440 — COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
- K941584 — CREATINE KINASE METHOD
- K941603 — AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE
- K941721 — EMC MODEL NO. 322870 ENDOSTAT
- K941771 — BODYWISE PREGNANCEY TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.