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
135097–135120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1988
EMIT CONVENIENCE PACK: T-UPTAKE ASSAY
K881855 · KHQ
Syva Co.
Chemistry · 38d
Cleared Jun 10, 1988
COBAS EIA(TM) PHOTOMETER
K881877 · JJQ
Roche Diagnostic Systems, Inc.
Chemistry · 37d
Cleared Jun 10, 1988
IQ HDL CHOLESTEROL
K881891 · LBS
Bd Becton Dickinson Vacutainer...
Chemistry · 36d
Cleared Jun 10, 1988
PHARMACIA IGE RIACT
K881892 · DGC
Pharmacia, Inc.
Immunology · 37d
Cleared Jun 10, 1988
ACE SCREW REMOVAL TREPHINE
K882008 · HWE
Buckman Co., Inc.
Orthopedic · 28d
Cleared Jun 10, 1988
CRANK FRAME RETRACTOR
K882071 · GZT
Karlin Technology, Inc.
Neurology · 24d
Cleared Jun 10, 1988
FLOSS CARD
K882164 · JES
Arthur Blank & Co., Inc.
Dental · 17d
Cleared Jun 09, 1988
DISPOSABLE CATHETER PRESSURE TRANSDUCER
K874165 · DXO
Deseret Medical, Inc.
Cardiovascular · 240d
Cleared Jun 09, 1988
VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT
K880040 · DSY
D-R Medical Systems, Inc.
Cardiovascular · 156d
Cleared Jun 09, 1988
SHILEY FEMORAL CANNULAE INTRODUCER KIT
K881073 · DRE
Shiley, Inc.
Cardiovascular · 87d
Cleared Jun 09, 1988
LIFESTAT 1600 PRINTER
K881346 · DSF
Physio-Control Corp.
Cardiovascular · 71d
Cleared Jun 09, 1988
RIGHT ATRIAL CATHETER INSERTION TRAY
K881352 · DWF
Quinton, Inc.
Cardiovascular · 71d
Cleared Jun 09, 1988
DURACLEAN DAILY CLEANER
K881987 · LPN
Allergan Optical
Ophthalmic · 29d
Cleared Jun 09, 1988
S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM
K882190 · LJT
Harbor Medical Devices, Inc.
General Hospital · 16d
Cleared Jun 08, 1988
SNAP CAMPYLOBACTOR DIAGNOSTIC KIT
K873670 · LQO
Molecular Biosystems, Inc.
Microbiology · 271d
Cleared Jun 08, 1988
EXTENDED MULTIPURPOSE TRANSDUCER RANGE
K880580 · IYO
Pie Medical USA BV
Radiology · 119d
Cleared Jun 08, 1988
RID PLATE READER
K881174 · JZQ
The Binding Site, Ltd.
Immunology · 82d
Cleared Jun 08, 1988
TEMPA-DOT CLINICAL THERMOMETER SHEATH
K881286 · FQZ
Pymah Corp.
General Hospital · 75d
Cleared Jun 08, 1988
NOVA LITE(TM) AUTOANTIBODY CONTROLS
K881340 · LLL
Inova Diagnostics, Inc.
Immunology · 71d
Cleared Jun 08, 1988
AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT
K881355 · JHI
Amersham Corp.
Chemistry · 51d
Cleared Jun 08, 1988
PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM
K881774 · CFT
Bd Becton Dickinson Vacutainer...
Chemistry · 43d
Cleared Jun 08, 1988
IMPRES-MB
K881801 · JHW
Intl. Immunoassay Laboratories, Inc.
Chemistry · 42d
Cleared Jun 07, 1988
SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY
K874902 · BZM
Gomi Medical Instruments
Anesthesiology · 189d
Cleared Jun 07, 1988
AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200
K880654 · JIW
American Research Products Co.
Chemistry · 111d