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
163897–163920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1981
T4 RIA KIT
K810811 · CDX
Immuno Assay Corp.
Chemistry · 14d
Cleared Apr 07, 1981
PREFILLED ARTERIAL BLOOD SAMPLING SYRING
K810816 · JKA
Current Technologies, Inc.
Hematology · 14d
Cleared Apr 06, 1981
SURU INFUSION SET TYPE J
K802169 · FPA
Suru Chemicals & Pharmaceuticals, Ltd.
General Hospital · 210d
Cleared Apr 06, 1981
SURU BLOOD COLLECTION SET
K802170 · FPA
Suru Chemicals & Pharmaceuticals, Ltd.
General Hospital · 210d
Cleared Apr 03, 1981
SERIES 810 PLATELET ANALYZER
K803128 · GKL
J.T. Baker Chemical Co.
Hematology · 112d
Cleared Apr 03, 1981
FASHION SUNGLASSES
K803308 · HQY
Grand Imperial, Inc.
Ophthalmic · 94d
Cleared Apr 03, 1981
SYNAP-I INFANT SENSORY ASSESSMENT UNIT
K810138 · GWJ
Infant Hearing Assessment Foundation
Neurology · 72d
Cleared Apr 03, 1981
PROGRAMMABLE SPINAL CORAL STIM. SYSTEM
K810182 · GZB
Electronic Diagnostics, Inc.
Neurology · 71d
Cleared Apr 03, 1981
EYEGLASS FRAMES
K810278 · HQZ
Caesar Intl. Designs
Ophthalmic · 60d
Cleared Apr 03, 1981
FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE
K810503 · NWS
Olympus Corp.
Gastroenterology & Urology · 38d
Cleared Apr 03, 1981
RICH-MAR HV II SELECT-A-PULSE
K810526 · IMG
Rich-Mar Corp.
Physical Medicine · 36d
Cleared Apr 03, 1981
EMIT-ST SERUM BARBITURATE ASSAY
K810602 · DIS
Syva Co.
Toxicology · 28d
Cleared Apr 03, 1981
ANTIMICROBIAL REMOVAL DEVICE
K810613 · MDB
Marion Laboratories, Inc.
Microbiology · 28d
Cleared Apr 03, 1981
ELECTROSURGICAL CUTTING & COAGULATION
K810628 · JOS
Intermedics, Inc.
General & Plastic Surgery · 25d
Cleared Apr 03, 1981
SHILEY OXYGENATOR THERMISTOR PROBE
K810647 · DWC
Shiley, Inc.
Cardiovascular · 23d
Cleared Apr 03, 1981
PENTAX COLONOSCOPE MODEL FC-34LA
K810682 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 21d
Cleared Apr 03, 1981
I.M. SCALPEL HANDLE
K810720 · GDZ
Instrument Makar, Inc.
General & Plastic Surgery · 17d
Cleared Apr 03, 1981
TAB PEDIATRIC CRIB
K810728 · FMS
Cambridge Scientific
General Hospital · 17d
Cleared Apr 03, 1981
SQUINN VITATEK 500 SERIES PHYSIOL. MONI
K810755 · DRT
Vitatek
Cardiovascular · 14d
Cleared Apr 03, 1981
API TURBICITY STANDARD
K810762 · JKP
Analytical Products, Inc.
Chemistry · 11d
Cleared Apr 03, 1981
QUANTIMUNE FERRITIN IRMA
K810799 · JMG
Bio-Rad
Chemistry · 11d
Cleared Apr 03, 1981
CARDIOPULMONARY BYPASS
K810820 · DWF
Dlp, Inc.
Cardiovascular · 10d
Cleared Apr 03, 1981
NEONATAL BLOOD PRESSURE CUFF
K810838 · DXQ
Invivo Research Labs, Inc.
Cardiovascular · 7d
Cleared Apr 02, 1981
VASCULAR TIE (VAS-TIE)
K810080 · KDC
Sil-Med Corp.
General & Plastic Surgery · 79d