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
133681–133704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1988
SUREBREATH DOME
K884076 · GAD
Ipax, Inc.
General & Plastic Surgery · 10d
Cleared Oct 06, 1988
POCKET MANOMETER
K880599 · DXN
Abbott Laboratories
Cardiovascular · 238d
Cleared Oct 06, 1988
MICROMEDIC CRACKPOT RIA KIT
K880674 · KLN
Icn Micromedic Systems
Toxicology · 230d
Cleared Oct 06, 1988
B. FRAGTEX
K881380 · JSP
American Biomedical Products, Inc.
Microbiology · 188d
Cleared Oct 06, 1988
HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT
K881983 · LWJ
Howmedica Corp.
Orthopedic · 147d
Cleared Oct 06, 1988
CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST
K882199 · LYR
Auspharm Intl. , Ltd.
Microbiology · 134d
Cleared Oct 06, 1988
PACER SENSING ANALYZER (PSA 100)
K882327 · DTC
Oscor Medical Corp.
Cardiovascular · 122d
Cleared Oct 06, 1988
SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR
K882380 · DTN
Scimed Life Systems, Inc.
Cardiovascular · 119d
Cleared Oct 06, 1988
AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200
K882475 · LFX
Amersham Corp.
Microbiology · 113d
Cleared Oct 06, 1988
BLUE DOT(TM) TEST FOR PREGNANCY
K882588 · LCX
V-Tech, Inc.
Chemistry · 105d
Cleared Oct 06, 1988
AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190
K882728 · JJY
Amersham Corp.
Chemistry · 97d
Cleared Oct 06, 1988
LANTOR CUBE STERILIZER TEST PACK
K882756 · JOJ
Lantor Group
General Hospital · 93d
Cleared Oct 06, 1988
POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP
K883015 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 79d
Cleared Oct 06, 1988
USCI SOFT-TIP ANGIOGRAPHIC CATHETER
K883051 · DQO
C.R. Bard, Inc.
Cardiovascular · 79d
Cleared Oct 06, 1988
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL
K883147 · JJY
Utak Laboratories, Inc.
Toxicology · 72d
Cleared Oct 06, 1988
HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER
K883297 · DQA
Hewlett-Packard Co.
Anesthesiology · 63d
Cleared Oct 06, 1988
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY
K883305 · CGJ
Binax, Inc.
Chemistry · 63d
Cleared Oct 06, 1988
BINAS LUTEINIZING HORMONE IRMA TEST KIT
K883306 · JIT
Binax, Inc.
Chemistry · 63d
Cleared Oct 06, 1988
FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI
K883352 · LJP
Whittaker Bioproducts, Inc.
Microbiology · 58d
Cleared Oct 06, 1988
CHLORIDE
K883386 · CHJ
Tech-Co, Inc.
Chemistry · 57d
Cleared Oct 06, 1988
DENTREK BRIDGE BARS
K883388 · EHO
Dale T. Dupuis
Dental · 57d
Cleared Oct 06, 1988
ALBABOND E
K883511 · EJS
Degussa Dental, Inc.
Dental · 50d
Cleared Oct 06, 1988
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE
K883523 · DRO
Cardiotronics, Inc.
Cardiovascular · 50d
Cleared Oct 06, 1988
HISTO-CHECK LEGIONELLA CONTROL SLIDES
K883567 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d