FDA 510(k) clearances — page 1330
clearances on record, most recent first.
Clearances — page 1330
132,901–133,000 of 175,890- K890332 — RFA/2 RAPID FLOW ANALYZER W/COMPUTER
- K890333 — ALBUMIN REAGENT
- K890335 — SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.
- K890398 — RYAN-STYLE DIRECTED INFUSION MANIPULATOR
- K890415 — SPQ(TM) ANTIBODY REAGENT SET II FOR AAT
- K890417 — SPQ(TM) ANTIBODY REAGENT SET II FOR C3
- K890423 — V-TREND TARGET CRP TEST
- K890564 — SPQ(TM) ANTIBODY REAGENT SET II FOR C4
- K890567 — BITE BLOCK #59430
- K890616 — BION DIRECT IDENTIFICATION CONTROL SLIDE
- K890625 — JAMES REAGENT
- K882630 — PRO DISCS
- K882636 — ALN DISCS
- K884312 — ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270
- K884680 — KODAK SURECELL HERPES (HSV) TEST KIT
- K884765 — CLINICAL ELECTRONIC THERMOMETERS
- K884912 — ANGIOSTAR
- K885028 — COULTER 5P CONTROL
- K885127 — SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM
- K885180 — EXPANDABLE BILIARY STENT ENDOPROSTHESIS
- K885310 — MURINE MONOCLONAL ANTI-ADENOVIRUS IGG
- K890097 — KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 1000
- K890146 — WELLCOLEX COLOUR SALMONELLA TEST ZL 50
- K890216 — MICROSURGICAL KERATOME
- K890383 — HYSTERECTOMY FORCEPS
- K890467 — KODAK PORTABLE IDENTIFICATION CAMERA
- K881765 — CTS-3060 AUTOMATED SEMEN ANALYZER
- K884834 — XOMED IONESTHETIZER(TM)
- K884933 — ENDOSTROBOSCOPE IV
- K890560 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGA
- K885090 — HOMER MAMMALOK LOCALIZATION SHIELD
- K885340 — AIR DISPLACEMENT PIPETTE
- K890040 — MODIFIED LABELING & PACKAGING OF SHARPLAN 2100
- K890128 — FACELOCK FILTER MASK
- K890309 — MALIS SURGICAL STOOL
- K890542 — MULTIWELL CULTURE PLATE INSERTS
- K882417 — POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT
- K883189 — MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
- K884046 — AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500
- K884371 — MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
- K884372 — MADSEN IGO1500 INSERTION GAIN OPTIMIZER
- K884503 — ULTRASONIC TRANSMISSION GEL
- K884833 — ULTRA 2000 (T.E.N.S.)
- K884918 — PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER
- K884960 — ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL
- K884961 — ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL
- K885010 — TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING
- K885075 — ABIOMED PERIOTEMP(TM) PROBE
- K885233 — NOVA DIAMOND
- K885250 — ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS
- K885302 — GOLD/PALLADIUM BASED DENTAL ALLOY
- K890085 — SIT-N-BATHE SITZ BATH
- K890156 — IMPACTOR FOR FEMORAL HEAD
- K890157 — FORCEPS
- K890158 — RETRACTORS
- K890160 — GOUGES FOR FEMORAL HEADS
- K890161 — THOMPSON TYPE RASP W/TOMMY BAR
- K890162 — EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD
- K890163 — AUSTIN MOORE HALLOW CHISEL
- K890164 — HUDSON BRACE W/BURRS
- K890165 — FORCEPS-ORTHOPEDIC
- K890166 — RONGUER-ORTHOPEDIC
- K890168 — RETRACTOR, SELF-RETAINING
- K890357 — DENTAL IMPRESSION SYINGE
- K890375 — VAGINAL SPECULUM
- K890377 — FIXED-SIZE UTERINE DILATOR
- K890378 — UTERINE DRESSING FORCEPS
- K890379 — UTERINE TENTACULUM
- K890384 — UTERINE CURETTE
- K890386 — PLACENTA AND OVUM FORCEPS
- K890388 — CEPHALOTOMY SCISSORS
- K890389 — UMBILICAL SCISSORS
- K890464 — ZENITH 40% PHOSPHORIC ACID GEL
- K890548 — AQUACISER SYSTEM
- K890553 — CP&S DISPOSABLE INSTANT COLD COMPRESS
- K890554 — CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS
- K890555 — PATIENT MOVER(TM)
- K883977 — SURGI-CUF STERILE/NON-STERILE DISPOSABLE
- K884547 — CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673
- K884733 — AFP MODEL 262T PULSE GENERATOR
- K884771 — IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY
- K884798 — AME PINSITE SHIELD(TM)
- K884830 — DENTAL CHAIR F1
- K884845 — STERI-OSS
- K884864 — PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO
- K884899 — DADC '500' DRIVING CONTROL
- K885094 — BIOTROL ALBUMIN
- K885134 — CLINISTAT TRIGLYCERIDES REAGENT TEST
- K885143 — ABSORBENT GAUZE ROLL
- K885157 — VENTREX COATED TUBE HIGH SENSITIVITY TSH
- K885240 — MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD
- K885265 — HDL CHOLESTEROL TEST
- K890064 — DENTAL SYRINGE APPLICATION TIP
- K890135 — IMX FOLLICLE STIMULATING HORMONE (FSH)
- K890304 — IRON REAGENTS ITEM NUMBER: SR1017
- K890406 — DETECTABUSE DRUG CONTROLS
- K890451 — EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR
- K890452 — EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR
- K890482 — ABC, ABC-1X, ABC(TM)
- K890501 — SECOND ASSISTANT
Data sourced from openFDA. This site is unofficial and independent of the FDA.