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
116353–116376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1992
DENLEY WELLPREP 2 SAMPLE PROCESSOR
K922327 · JQW
Denley Instruments, Inc.
Hematology · 93d
Cleared Aug 12, 1992
VACU-PRO
K922445 · JKA
Concord/Portex
Chemistry · 82d
Cleared Aug 12, 1992
DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO
K922696 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 69d
Cleared Aug 12, 1992
LIPID CONTROLS
K922995 · JJX
Creative Laboratory Products, Inc.
Chemistry · 51d
Cleared Aug 12, 1992
NOVA TOTAL PROTEIN MODULE
K923266 · CEK
Nova Biomedical Corp.
Chemistry · 41d
Cleared Aug 12, 1992
SILICONE BRAIN SPATULA SET
K923723 · HAO
Redmond Neurosurgical, Inc.
Neurology · 16d
Cleared Aug 11, 1992
DISPOSABLE HEMOSTATS
K920298 · HRQ
Falcon Instruments, Inc.
General & Plastic Surgery · 202d
Cleared Aug 11, 1992
CANNULA NASAL OXYGEN
K920573 · CAT
B & F Medical Products, Inc.
Anesthesiology · 186d
Cleared Aug 11, 1992
TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER
K920948 · KPJ
Topox Therapeuutic Rentals, Inc.
General & Plastic Surgery · 162d
Cleared Aug 11, 1992
DISPOSABLE ISOLATION GOWN
K921058 · FYC
Nat'L Surtex Corp.
General Hospital · 159d
Cleared Aug 11, 1992
ORTHO CHLAMYDIA ANTIGEN ELISA TEST
K921321 · LJC
Ortho Diagnostic Systems, Inc.
Microbiology · 148d
Cleared Aug 11, 1992
GEN-X 800/6/50
K921539 · KPR
Swiss Ray Medical Systems
Radiology · 132d
Cleared Aug 11, 1992
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
K921616 · LIN
Incstar Corp.
Microbiology · 127d
Cleared Aug 11, 1992
PHILIP XP SERIES, IN-THE CANAL HEARING AID
K921725 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 124d
Cleared Aug 11, 1992
7000 SERIES TOTAL KNEE MODULAR COMPONENT CEMENT CA
K922104 · JWH
Osteonics Corp.
Orthopedic · 97d
Cleared Aug 11, 1992
OSTRONCS HEMI-HIP STEM SERIES
K922146 · KWL
Osteonics Corp.
Orthopedic · 96d
Cleared Aug 11, 1992
WELLPREP 2000 SAMPLE PROCESSOR
K922183 · JQW
Denley Instruments, Inc.
Chemistry · 92d
Cleared Aug 11, 1992
BIO THERAPY PLUS
K922205 · FNM
Sunrise Medical, Inc.
General Hospital · 91d
Cleared Aug 11, 1992
DYNASTY ISOLATION GOWN
K922234 · FYC
Dynatech Medical Products
General Hospital · 90d
Cleared Aug 11, 1992
INSTRUMENT, MANUAL, GENERAL SURGICAL
K922571 · GCJ
Symbiosis Corp.
General & Plastic Surgery · 71d
Cleared Aug 11, 1992
PHILIPS CARDIAC WORKSTATION
K922622 · IZI
Philips Medical Systems, Inc.
Radiology · 69d
Cleared Aug 11, 1992
COLOR DISKSTORE
K922647 · IYO
Camtronics, Ltd.
Radiology · 69d
Cleared Aug 11, 1992
IRIS OCULIGHT SL
K922663 · GEX
Iriderm Div.
General & Plastic Surgery · 82d
Cleared Aug 11, 1992
CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSIS
K922671 · KPS
Nuccardiac Software, Inc.
Radiology · 68d