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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
114145–114168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 1993
DC-UIBC-CAL
K925877 · JIS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 119d
Cleared Mar 18, 1993
RSTAR IMAGE MANAGMENT SYTEM (RSTAR-IMS)
K925994 · LMD
Rstar, Inc.
Radiology · 111d
Cleared Mar 18, 1993
JPI ALUMINUM INTERSPACED X-RAY GRID
K926261 · IXJ
Jpi, Inc.
Radiology · 90d
Cleared Mar 18, 1993
PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG
K926356 · JHI
Becton Dickinson Advanced Diagnostics
Chemistry · 87d
Cleared Mar 18, 1993
FAST SPIN ECHO MEASURING FUNCTION
K926397 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 87d
Cleared Mar 18, 1993
SIS-300(N)-DIA SCAN
K926434 · JAA
Micro-Focus Imaging., Inc.
Radiology · 85d
Cleared Mar 18, 1993
UNIX-LINK
K926550 · IYX
General Electric Co.
Radiology · 77d
Cleared Mar 18, 1993
AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT
K926563 · CDX
Bio-Chem Laboratory Systems, Inc.
Chemistry · 77d
Cleared Mar 18, 1993
BEHIND-THE-EAR HEARING AID
K930271 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 58d
Cleared Mar 18, 1993
APEX SPECIMEN BAG
K930313 · LIO
Apex Medical Technologies, Inc.
Microbiology · 55d
Cleared Mar 18, 1993
OTOSONIC FSD, IN-THE-EAR HEARING AID
K930598 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 41d
Cleared Mar 18, 1993
PRECISE PREGNANCY
K930640 · LCX
Bd Becton Dickinson Vacutainer...
Chemistry · 49d
Cleared Mar 18, 1993
WIDEX MODEL DX HEARING AID
K930715 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 35d
Cleared Mar 18, 1993
CE-9 IN-THE-EAR HEARING AID
K930805 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared Mar 18, 1993
INTRA V AND SECRET EAR III
K930853 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Mar 16, 1993
PALCO LABS MODEL 340 PULSE OXIMETER
K920066 · DQA
Palco Laboratories, Inc.
Anesthesiology · 434d
Cleared Mar 16, 1993
AMERICANA HIP PROTHESIS
K922682 · JDG
Osteo Technology, Inc.
Orthopedic · 285d
Cleared Mar 16, 1993
DURACON METAL BACKED PATELLA
K923573 · JWH
Howmedica Corp.
Orthopedic · 242d
Cleared Mar 16, 1993
PALA-NATE
K923591 · BTR
Gesco Intl., Inc.
Anesthesiology · 239d
Cleared Mar 16, 1993
SYMPHONY
K923714 · EJT
J.F. Jelenko & Co., Inc.
Dental · 232d
Cleared Mar 16, 1993
JELENKO PORCELAIN SYSTEM PVS PROCELAIN
K923717 · EIH
J.F. Jelenko & Co., Inc.
Dental · 232d
Cleared Mar 16, 1993
DENTAL DIAMOND DRILLS
K923757 · DZP
Alpha Industrializacao DE Metais Ltda.
Dental · 231d
Cleared Mar 16, 1993
SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM
K923984 · LNH
Shimadzu Medical Systems
Radiology · 221d
Cleared Mar 16, 1993
SYMBIOSIS DISPOSABLE ARTHROSCOPIC SURGICAL INST.
K924017 · HRX
Symbiosis Corp.
Orthopedic · 217d