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
158737–158760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1982
PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC
K820882 · DSP
Datascope Corp.
Cardiovascular · 202d
Cleared Oct 18, 1982
DIALYZER REPROCESSING SYSTEM DRS-4
K821863 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 116d
Cleared Oct 18, 1982
NON-STETHO 7, UM-15TP
K821989 · DXN
Hirata Sangyo Co. USA, Inc.
Cardiovascular · 103d
Cleared Oct 18, 1982
ALPHA-TOXIN DISCS
K821992 · JTO
Microchemical Specialities, Co.
Microbiology · 103d
Cleared Oct 18, 1982
SIEMENS SIRECUST SYSTEM
K822091
Analogic Corp.
Cardiovascular · 95d
Cleared Oct 18, 1982
SERAGAN ACTH125 I-RIA KIT
K822115 · CKG
Seragen Diagnostics, Inc.
Chemistry · 91d
Cleared Oct 18, 1982
LARYNGEAL SYRINGE
K822185 · FMF
Kelleher Corp.
General Hospital · 87d
Cleared Oct 18, 1982
BLOOD CELL DILUENT 78N 1913
K822325 · GIF
Interscience, Inc.
Hematology · 76d
Cleared Oct 18, 1982
BLENDED DETERGENT-78N 1912-1
K822326 · PPM
Interscience, Inc.
Hematology · 76d
Cleared Oct 18, 1982
SURGICARE MODEL 1000
K822447
Surgicare Scientific Laboratory, Inc.
General & Plastic Surgery · 63d
Cleared Oct 18, 1982
SYRINGE PUMP 209-100
K822454 · FRN
Medix Corp.
General Hospital · 63d
Cleared Oct 18, 1982
CRITICAL MEASUREMENT UNIT
K822556 · BYZ
Bemis Health Care
General Hospital · 55d
Cleared Oct 18, 1982
SPECIMEN ADAPTOR
K822557 · BYZ
Bemis Health Care
General Hospital · 55d
Cleared Oct 18, 1982
TEFLON COATED GUIDE WIRES & CATHETER
K822586 · DQX
Universal Medical Instrument Corp.
Cardiovascular · 53d
Cleared Oct 18, 1982
LS6 ARRYTHMIA DISCRIMINATOR
K822616 · DSI
Life Science Instrumentation, Inc.
Cardiovascular · 49d
Cleared Oct 18, 1982
C-200 INFANT INCUBATOR
K822656 · FMZ
Narco Scientific
General Hospital · 45d
Cleared Oct 18, 1982
CLEAN-N-SOAK
K822707 · HPX
Allergan, Inc.
Ophthalmic · 41d
Cleared Oct 18, 1982
HEMOTECT
K822731 · KHE
Bio-Chem Laboratories
Hematology · 35d
Cleared Oct 18, 1982
AHBD
K822739 · JMK
Gilford Diagnostics
Chemistry · 39d
Cleared Oct 18, 1982
PILLING LACRIMAL INTUBATION SYSTEM(STER.
K822747
Narco Scientific
General & Plastic Surgery · 38d
Cleared Oct 18, 1982
SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY
K822758 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 34d
Cleared Oct 18, 1982
NEGATIVE PRESSURE ARTERIAL BLOOD LINE
K822796 · KOC
Erika, Inc.
Gastroenterology & Urology · 32d
Cleared Oct 18, 1982
GAS-FLOW METER GFL 10
K822820 · DTX
Gambro, Inc.
Cardiovascular · 28d
Cleared Oct 18, 1982
GAMBRO BLOOD LEVEL DETECTOR LCS 10
K822821 · DTW
Gambro, Inc.
Cardiovascular · 28d