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
155857–155880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1983
P.C.A. UNICOMPARTMENTAL KNEE PROSTHES
K831143 · HRY
Howmedica Corp.
Orthopedic · 131d
Cleared Aug 16, 1983
ANCHOR BRAND SURGICAL NEEDLES
K831648 · GAB
Anchor Products Co.
General & Plastic Surgery · 85d
Cleared Aug 16, 1983
CONTINU-FLO SOLUTION ADMINISTRATION
K831668 · FPB
Travenol Laboratories, S.A.
General Hospital · 85d
Cleared Aug 16, 1983
FOIL IN 3 FORMS-NON-STERILE SHEETS
K831725 · FTM
S. Jackson, Inc.
General & Plastic Surgery · 77d
Cleared Aug 16, 1983
IMPLANTABLE PROGRAM. CARDIAC PULSE GEN
K831771 · DXY
Telectronics, Inc.
Cardiovascular · 75d
Cleared Aug 16, 1983
MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK
K831773 · HQJ
Bcd Products, Inc.
Ophthalmic · 75d
Cleared Aug 16, 1983
SETS & TRAYS
K831794
I M, Inc.
General & Plastic Surgery · 74d
Cleared Aug 16, 1983
TEXAS INTERFACE PRESSURE EVALUATOR-TIPE
K831800 · JFC
Tee-Kay Applied Technology
Physical Medicine · 85d
Cleared Aug 16, 1983
INSPIREASE
K832037 · CCQ
Key Pharmaceuticals, Inc.
Anesthesiology · 53d
Cleared Aug 16, 1983
EVOKED 3500 POTENTIAL SYSTEM
K832084 · GWE
Tracor Northern, Inc.
Neurology · 49d
Cleared Aug 16, 1983
LENSOMETER
K832085
CooperVision, Inc.
Ophthalmic · 49d
Cleared Aug 16, 1983
A.M.S. TEMP. SCAN 300
K832135 · FLL
Andon Medical Systems, Inc.
General Hospital · 46d
Cleared Aug 16, 1983
TA-400 TEMP. FEEDBACK DEVICE
K832146 · HCC
Spectral Data Systems
Neurology · 42d
Cleared Aug 16, 1983
DHEA-SULFATE I RIA KIT
K832154 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 42d
Cleared Aug 16, 1983
CHOLESTEROL HIGH PERFORMANCE-K
K832158 · CHH
Boehringer Mannheim Corp.
Chemistry · 42d
Cleared Aug 16, 1983
UNITIZED ENZYMATIC GLUCOSE TEST SET
K832159 · CGA
Stanbio Laboratory
Chemistry · 42d
Cleared Aug 16, 1983
FLO-GARD 8500 MICROINFUSION PUMP
K832166 · FRN
Travenol Laboratories, S.A.
General Hospital · 42d
Cleared Aug 16, 1983
CORPAK VTR 300 ENTERNAL PUMP
K832167 · FRN
Corpak Co.
General Hospital · 42d
Cleared Aug 16, 1983
TOTAL PROTEIN PROCEDURE
K832169 · CEK
Sandare Chemical Co., Inc.
Chemistry · 41d
Cleared Aug 16, 1983
DIGILAB 350 THE KRAKAU PERIMETER
K832175 · HPT
Bio-Rad
Ophthalmic · 41d
Cleared Aug 16, 1983
HC40/HC75 CATION EXCHANGE RESIN
K832199 · DNH
Hamilton Co.
Toxicology · 40d
Cleared Aug 16, 1983
PRP-1 REVERSED PHASE COLUMNS FOR HPLC
K832200 · DPM
Hamilton Co.
Toxicology · 40d
Cleared Aug 16, 1983
CHROM-PREP
K832201 · KZR
Hamilton Co.
Toxicology · 40d
Cleared Aug 16, 1983
ORTHOPEDIC CASTING TAPE MAXCAST
K832237 · ITG
Cutter Laboratories, Inc.
Physical Medicine · 36d