FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
135697–135720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 07, 1988
BABYROCKER
K881019 · FMS
Cinventa AB
General Hospital · 89d
Cleared Jun 07, 1988
PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER
K881099 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 84d
Cleared Jun 07, 1988
BILIRUBIN (DIRECT)
K881172 · CIG
Tech-Co, Inc.
Chemistry · 81d
Cleared Jun 07, 1988
ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)
K881173 · CIQ
Tech-Co, Inc.
Chemistry · 81d
Cleared Jun 07, 1988
DYNATECH SPD 2000, NUMBER 002-910-0000
K881195 · JQW
Dynatech Laboratories, Inc.
Chemistry · 78d
Cleared Jun 07, 1988
GENT-L-KARE VAGINAL IRRIGATION SET
K881216 · HED
Geneva Laboratories, Inc.
Obstetrics & Gynecology · 77d
Cleared Jun 07, 1988
BION HSV1-G OR HSV2-G TEST SYSTEM
K881261 · GQO
Bion Ent., Ltd.
Microbiology · 75d
Cleared Jun 07, 1988
DAHLBERG MODEL GP BODY AID
K881417 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 64d
Cleared Jun 07, 1988
INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY
K881617 · LSE
Granbio, Inc.
Microbiology · 53d
Cleared Jun 07, 1988
IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT
K881661 · EMA
Specialites Septodont
Dental · 53d