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
120793–120816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1991
ENTREE CANNULA
K911813 · FBM
Core Dynamics, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 19, 1991
IMMUNOCARD HCG ONE STEP (I-S) TEST KIT
K911826 · JHI
Disease Detection International, Inc.
Chemistry · 86d
Cleared Jul 19, 1991
ROCHE REAGENT FOR C02
K911838 · CHS
Roche Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jul 19, 1991
X-MARX
K911873 · JAC
Macbrud Corp. Medical Div.
Radiology · 81d
Cleared Jul 19, 1991
CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM
K911943 · ILO
Burke, Inc.
Physical Medicine · 79d
Cleared Jul 19, 1991
OLYMPIC WARMETTE
K911955 · LDQ
Olympic Medical Corp.
General & Plastic Surgery · 79d
Cleared Jul 19, 1991
MAGNETOM P8 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K911991 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 74d
Cleared Jul 19, 1991
AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)
K912024 · JJE
Wako Chemicals USA, Inc.
Chemistry · 77d
Cleared Jul 19, 1991
TARGET MICROALBUMINURIA TEST
K912246 · JIR
Texas Immunology, Inc.
Chemistry · 59d
Cleared Jul 19, 1991
LASER BEAM LOCALIZER FOR SIREMOBIL 4
K912380 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 51d
Cleared Jul 19, 1991
ELECTROLYTE CONTROL
K912513 · JJR
Verichem Laboratories, Inc.
Chemistry · 43d
Cleared Jul 19, 1991
MICRO ALBUMIN EIA TEST KIT
K912543 · JIR
Immuno Diagnostic Center, Inc.
Chemistry · 39d
Cleared Jul 19, 1991
SALTER LABS INFANT MEDIUM CONCENTRATION MASK
K912633 · BYG
Salter Labs
Anesthesiology · 35d
Cleared Jul 19, 1991
SURGICAL SAW BLADES
K912761 · GFA
Blairden Precision Instruments, Inc.
General & Plastic Surgery · 25d
Cleared Jul 19, 1991
PERRY NATURAL POWDER FREE GLOVES
K912797 · KGO
Smith & Nephew, Inc.
General Hospital · 24d
Cleared Jul 18, 1991
FUTURECARE CARELYNK IV SYSTEM
K903512 · DRT
Futurecare Systems, Inc.
Cardiovascular · 349d
Cleared Jul 18, 1991
DATAMED MODEL 401A TRANSRECIEVER
K904966 · DXH
Datamed, Inc.
Cardiovascular · 255d
Cleared Jul 18, 1991
MODEL 8604-FO PULSE OXIMETER
K910001 · DQA
Nonin Medical, Inc.
Anesthesiology · 197d
Cleared Jul 18, 1991
IPI ALGO-LINE CATHETER
K911382 · MAJ
Pudenz-Schulte Medical Research Corp.
General Hospital · 112d
Cleared Jul 18, 1991
INJECTOR FILL TUBE
K911549 · DXT
The R Group
Cardiovascular · 101d
Cleared Jul 18, 1991
MAGNETIC HDL CHOLESTEROL TEST
K911906 · LBR
Reference Diagnostics, Inc.
Chemistry · 79d
Cleared Jul 18, 1991
KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST
K912251 · CFR
King Diagnostics, Inc.
Chemistry · 58d
Cleared Jul 18, 1991
CALCITONIN KIT MITSUBISHI YUKA
K912536 · JKR
Mitsubishi Yuka America, Inc.
Chemistry · 41d
Cleared Jul 18, 1991
K-CAP-I, STERILE
K912762 · LYT
Westcon Orthopedics, Inc.
Orthopedic · 24d