FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
141625–141648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1986
CHOLESTEROL
K863927 · CHH
Tech-Co, Inc.
Chemistry · 47d
Cleared Nov 24, 1986
LUTEINIZING HORMONE (LH-IRMA) RIA KIT
K864144 · CEP
Immuchem Corp.
Chemistry · 33d
Cleared Nov 24, 1986
PROGESTERONE SYSTEM BY EIA
K864156 · JLS
Intl. Bioclinical, Inc.
Chemistry · 32d
Cleared Nov 24, 1986
THERMONUCLEASE AGAR W/TOLUIDINE BLUE
K864205 · JSH
Remel Co.
Microbiology · 28d
Cleared Nov 24, 1986
VISION (TM) GGTP
K864208 · JPZ
Abbott Laboratories
Chemistry · 28d
Cleared Nov 24, 1986
SILIVA EJECTOR/ORAL CAVITY EVACUATOR
K864300 · DYN
Ardent Intl., Inc.
Dental · 24d
Cleared Nov 24, 1986
ACUSYST-P (CELL CULTURE EQUIPMENT)
K864334 · KJH
Endotronics, Inc.
Pathology · 20d
Cleared Nov 24, 1986
WILLIAMS ORTHOPAEDIC SURGICAL INSTRUMENTS
K864340
Buckman Co., Inc.
Orthopedic · 20d
Cleared Nov 24, 1986
PENTRON HIGH STRENGTH PORCELAIN
K864404 · EIH
Pentron Corp.
Dental · 14d
Cleared Nov 24, 1986
RAYLOR(TM) MALLET
K864422 · HWA
Cedar Surgical, Inc.
Orthopedic · 14d
Cleared Nov 24, 1986
RAYLOR(TM) OSTEOTOMES
K864423
Cedar Surgical, Inc.
Orthopedic · 14d
Cleared Nov 24, 1986
MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY
K864461 · DWS
Medsurg Industries, Inc.
Cardiovascular · 12d
Cleared Nov 24, 1986
SPACELABS ARRHYTHMIA NET (TM) LEVEL 2
K864505 · DSI
Spacelabs, Inc.
Cardiovascular · 10d
Cleared Nov 22, 1986
EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES
K864011 · NAD
Fraass Survival Systems, Inc.
General & Plastic Surgery · 38d
Cleared Nov 21, 1986
PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE
K863366 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 79d
Cleared Nov 21, 1986
LIFE-WATCH MONITOR LT-8
K863534 · DRT
Computerized Medical Systems, Inc.
Cardiovascular · 71d
Cleared Nov 21, 1986
NELLCOR N-200 (PULSE OXIMETER)
K863784 · DQA
Nellcor, Inc.
Anesthesiology · 56d
Cleared Nov 21, 1986
CREST CERVICAL TRACTION
K863838
Central Equipment Sales, Inc.
Physical Medicine · 51d
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM
K863859 · JLW
Hybritech, Inc.
Chemistry · 49d
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN
K863860 · CFT
Hybritech, Inc.
Chemistry · 49d
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA
K863861 · JHI
Hybritech, Inc.
Chemistry · 49d
Cleared Nov 21, 1986
LYOFOAM C ODOR-ABSORBING DRESSING
K864084 · FRO
Acme United Corp.
General & Plastic Surgery · 32d
Cleared Nov 21, 1986
FISHER PRICE SUNJAMMERS
K864399 · HQY
Fisher Price
Ophthalmic · 15d
Cleared Nov 20, 1986
OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE
K860858 · LYK
Olympus Corp.
Cardiovascular · 258d