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
147505–147528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1985
PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM
K851528 · LQM
Pasco Laboratories, Inc.
Microbiology · 88d
Cleared Jul 15, 1985
DART IMMUNOGLOBULINS REAGENT SYSTEM
K851541 · DEW
Coulter Electronics, Inc.
Immunology · 90d
Cleared Jul 15, 1985
TMX-C1/C2 TRADMILL CONTROLLER ACCESS.
K851631 · IOL
Eaton Medical Group
Physical Medicine · 88d
Cleared Jul 15, 1985
EZZIE SYSTEM
K851740 · IQA
Independent Living, Inc.
Physical Medicine · 77d
Cleared Jul 15, 1985
SPINAL FLUID CONTROL
K851820 · JJY
Irvine Scientific
Chemistry · 80d
Cleared Jul 15, 1985
UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER
K851857 · KOD
Sheridan Catheter Corp.
Gastroenterology & Urology · 80d
Cleared Jul 15, 1985
OHMEDA GMS ABOSORBER
K852071 · BSF
Ohmeda Medical
Anesthesiology · 63d
Cleared Jul 15, 1985
PHADEBAS RAST TEST ALLERGEN DISCS
K852189 · DHB
Pharmacia, Inc.
Immunology · 56d
Cleared Jul 15, 1985
#3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
K852311 · CAI
Sigma Medical, Inc.
Anesthesiology · 47d
Cleared Jul 15, 1985
#3005 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
K852312 · CAI
Sigma Medical, Inc.
Anesthesiology · 47d
Cleared Jul 15, 1985
#3001 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
K852313 · CAI
Sigma Medical, Inc.
Anesthesiology · 47d
Cleared Jul 15, 1985
#3012 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
K852315 · CAI
Sigma Medical, Inc.
Anesthesiology · 47d
Cleared Jul 15, 1985
#3011 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
K852316 · CAI
Sigma Medical, Inc.
Anesthesiology · 47d
Cleared Jul 15, 1985
QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)
K852418 · JJY
Amf Biological and Diagnostics Co.
Immunology · 38d
Cleared Jul 15, 1985
MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94
K852482 · JPI
Em Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Jul 15, 1985
CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE
K852516 · JPI
Whittaker General Medical
Hematology · 32d
Cleared Jul 15, 1985
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K852589 · DEW
Abbott Laboratories
Immunology · 27d
Cleared Jul 15, 1985
AMRESCO CALCIUM REAGENT SET
K852657 · CIC
American Research Products Co.
Chemistry · 21d
Cleared Jul 15, 1985
IDENTICULT-AE
K852666 · JTO
Scott Laboratories, Inc.
Microbiology · 21d
Cleared Jul 15, 1985
RESPITRACE 300SC
K852692 · BZK
Respitrace Corp.
Anesthesiology · 19d
Cleared Jul 15, 1985
SCALPEL HANDLE #3 SS 410 OR 420
K852711 · GDZ
The Huxley Instrument Corp.
General & Plastic Surgery · 19d
Cleared Jul 15, 1985
MAYO SCISSORS, 6-3/4 CURVED SS 410 OR 420
K852712
The Huxley Instrument Corp.
General & Plastic Surgery · 19d
Cleared Jul 15, 1985
RUSSIAN TISSUE FORCEPS, 6 + SS 410 OR 420
K852713 · HTD
The Huxley Instrument Corp.
General & Plastic Surgery · 19d
Cleared Jul 15, 1985
MAYO DISSECTING SCISSORS, STRAIGHT, 5-1/2 + SS
K852714
The Huxley Instrument Corp.
General & Plastic Surgery · 19d