FDA 510(k) clearances — page 1275
clearances on record, most recent first.
Clearances — page 1275
127,401–127,500 of 176,637- K901123 — CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN
- K901345 — MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050
- K901965 — MPR-4A - MICRO-PLATE READER
- K894100 — OXYTRAK(TM) PULSE OXIMETER
- K895117 — HTO COMPRESSING STAPLE
- K896422 — BURRON AMBULATORY DRUG DELIVERY SYSTEM
- K896568 — DUALYSE-CATH - CODES #1132.212, 1132.112
- K900193 — MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT
- K900551 — MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC.
- K900628 — MODULAR HIP SYSTEM
- K900657 — UNIVERSAL DELIVERY SYSTEM CATHETER
- K900815 — SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL
- K900835 — MODIFIED PERM-CATH
- K900945 — LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING
- K900967 — MODIFIED ALPHA MC-9R C-ARM
- K901145 — NDM SWITCHPEN HOLSTER
- K901332 — PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
- K901358 — BARD BIOPOTENTIAL AMPLIFIER II
- K901385 — GABRIEL MEDICAL CLS THERMAL RECORDER
- K901506 — ANEROID SPHYGMOMANOMETER, DOCTOR TYPE
- K901924 — READS(R) ANTI-ENA (SM/RNP) TEST KIT
- K902001 — SURGICAL RETENTION BAR
- K893215 — VITAJET(INSULIN JET INJECTION DEVICE)
- K894828 — HPI ORTHO SURGEONS' GLOVE
- K895358 — THERMO-5000
- K896530 — FERMIT TEMPORARY MATERIAL
- K896708 — PERLINK CASSETTE, KIRAN CASSETTE
- K896755 — ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
- K896946 — COATED NOVAFIL, POLYBUTESTER, MESH
- K900135 — CU-75 VISIBLE LIGHT-CURING UNIT
- K900194 — MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
- K900342 — UNITY DENTAL CEMENT
- K900356 — THERMOAIRE SPLINT (TM) (TAS)
- K900388 — MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES
- K900633 — DISP. ELECTROSURGERY PENCIL, HAND CONTROL
- K900651 — TS-1800 MEDICATION TRANSFER SPIKE
- K900765 — STEEROCATH(TM)
- K900878 — OTT INSUFFLATION FILTER TUBING
- K900988 — AMCATH SUCTION-IRRIGATION TUBE
- K901053 — MIRROR SHIELD
- K901087 — MODIFIED PROFILE II ACETABULAR CUP PROSTHESIS
- K901228 — MULTI-STRIP
- K901405 — DIGIFORMER HR DFP-50A
- K901602 — VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000
- K901620 — MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI
- K901742 — INAMED SMALL DRAIN SYSTEM
- K901761 — STERILE SUCTION TUBING SET
- K901764 — INAMED CONVERTIBLE DRAIN SYSTEM
- K901794 — AIR CUSHIONED AUTO WHEELCHAIR LIFT ACL-200/AG-Z2
- K901890 — MARK IV FLOATATION THERAPY BED
- K892503 — NUFFIELD TOTAL KNEE
- K893039 — CONDOM (RUBBER) CONTRACEPTIVE
- K896288 — FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM
- K900630 — MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG
- K900726 — MICROTEK MEDICAL'S BLOOD COLLECTION KIT
- K900767 — B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE
- K900774 — DACOMED NEGATIVE PRESSURE ERECTION DEVICE
- K900832 — MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA.
- K901011 — BIOSIGN HCG-ONE STEP PREGNANCY TEST
- K901223 — VACUUM ERECTION DEVICE (VED)
- K901229 — CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)
- K901318 — STAYEREC SYSTEM(TM)
- K901603 — MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
- K894515 — LISS CRANIAL STIMULATOR MODEL SBL201-M
- K896575 — DANTEC MENUET
- K896919 — HEARTSTART 3000
- K900520 — MODEL N742 SUNGLASSES W/ACRYLIC NIGHT DRIVER LENS
- K900521 — MODEL N742 SUNGLASSES W/POLYCARBONATE BLUE BLOCKER
- K900522 — MODEL N741 SUNGLASSES W/ACRYLIC BLUE COMPUTER LENS
- K900524 — MODEL F3 FLIP UP SUNGLASSES W/POLORIZED COMPUTER
- K900526 — MODEL F 1 FLIP-UP SUNGLASSES W/POLORIZED LENS
- K900527 — MODEL S139029 SUNGLASSES W/MIRROR ACRYLIC LENSES
- K900528 — MODEL 8806 SD SUNGLASSES W/ACRYLIC LENSES
- K900529 — MODEL 9018 PC SUNGLASSES W/POLYCARBONATE LENSES
- K900539 — MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL
- K900543 — CHLAMYDIAZYME DIAGNOSTIC KIT
- K900566 — RICHARD-ALLAN VESSEL LOOPS
- K900751 — HERAEUS LASERSONICS CO2 WAVEGUIDE DELIVERY SYSTEM
- K900812 — MEDICAM ARTHROSCOPE SYSTEMS
- K900903 — KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE
- K900984 — MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
- K901008 — HEXASCAN HANDPIECE
- K901468 — CHILDREN'S SUNGLASSES
- K901707 — FORTRESS COMMUTER FT (FOLDING TRANSPORT)
- K901834 — INSTANT ICE PACK
- K901859 — COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2
- K895246 — FRENTA(R) DUO-SET
- K895330 — 600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA
- K895366 — ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE
- K895696 — ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU
- K895919 — ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III
- K895933 — ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III
- K896544 — MD2 PERSONAL INFUSION SYSTEM
- K896688 — URINE COLLECTOR LEG BAG
- K896695 — DYNA-FLO URINARY DRAINAGE BAG
- K896853 — PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA
- K897078 — ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
- K900110 — OPERAND* LUBRICATING JELLY
- K900196 — LYME IGM ELISA TEST SYSTEM
- K900485 — ENZYMUN TEST(R) CORTISOL
Data sourced from openFDA. This site is unofficial and independent of the FDA.