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
136417–136440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1988
SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM
K880188 · JDB
Howmedica Corp.
Orthopedic · 46d
Cleared Mar 01, 1988
BINAX PROLACTIN IRMA DIAGNOSTIC KIT
K880218 · CFT
Binax, Inc.
Chemistry · 41d
Cleared Mar 01, 1988
MSI-DIFF PLUS
K880270 · JPK
Medical Specialties, Inc.
Hematology · 40d
Cleared Mar 01, 1988
ALT (SGPT) REAGENT SET
K880275 · CKA
Tech-Neal Scientific, Inc.
Chemistry · 40d
Cleared Mar 01, 1988
WAKO(TM) AUTOKIT CHOLESTEROL
K880311 · CHH
Wako Chemicals USA, Inc.
Chemistry · 36d
Cleared Mar 01, 1988
IQ ALKALINE PHOSPHATASE
K880344 · CJK
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Mar 01, 1988
MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT
K880665 · GTZ
Allelix Diagnostics, Inc.
Microbiology · 12d
Cleared Feb 29, 1988
PHARMACLUSIVE (TM)
K872573 · NAD
Pharmacia, Inc.
General & Plastic Surgery · 245d
Cleared Feb 29, 1988
OLYMPUS ANGIOSCOPY SHEATH
K873100 · DYB
Olympus Corp.
Cardiovascular · 206d
Cleared Feb 29, 1988
PALL FIELD MEDICAL OXYGEN GENERA. & DISTRI. SYSTEM
K873526 · CAW
Pall Safety Atmospheres, Inc.
Anesthesiology · 181d
Cleared Feb 29, 1988
ASTHMAKIT
K874047 · CAF
Dhd Medical Products Div. Diemolding...
Anesthesiology · 147d
Cleared Feb 29, 1988
SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT
K874450 · BTO
Surgitech C/O Collier, Shannon, Rill...
Anesthesiology · 123d
Cleared Feb 29, 1988
RESUSCITATOR
K874567 · BTM
American Medical Technology, Inc.
Anesthesiology · 116d
Cleared Feb 29, 1988
GUARDIAN, EEG BRAIN MONITORING SYSTEM
K874733 · OLT
Tracor Northern, Inc.
Neurology · 103d
Cleared Feb 29, 1988
BIOSURGE MODEL ILVC-1
K875016 · DWS
Biosurge, Inc.
Cardiovascular · 87d
Cleared Feb 29, 1988
SCIMED INFLATION DEVICE, MODEL SM 2000
K875064 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 82d
Cleared Feb 29, 1988
BREATHE-FREE
K875073 · BYE
Cincinnati Medical Technologies, Inc.
Anesthesiology · 82d
Cleared Feb 29, 1988
AIR VENT LINE CAT. NO. AVL-36
K875080 · DTM
American Omni Medical, Inc.
Cardiovascular · 82d
Cleared Feb 29, 1988
AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K875090 · DXC
United States Surgical, A Division of...
Cardiovascular · 82d
Cleared Feb 29, 1988
ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT
K875091 · EBC
Mission White Dental, Inc.
Dental · 81d
Cleared Feb 29, 1988
ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE
K875094 · KRJ
Pall Biomedical Products Co.
Cardiovascular · 81d
Cleared Feb 29, 1988
PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE
K875095 · JOD
Pall Biomedical Products Co.
Cardiovascular · 81d
Cleared Feb 29, 1988
CIBA CORNING BALANCED HEPARIN FOR CA++
K875117 · CBT
Ciba Corning Diagnostics Corp.
Anesthesiology · 76d
Cleared Feb 29, 1988
PHASE II
K875142 · DYH
Reliance Orthodontic Products, Inc.
Dental · 76d