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
161065–161088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 1982
MODEL 343 HEARING AID
K820148 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 35d
Cleared Feb 23, 1982
EMIT FREELEVEL SYSTEM I
K820224 · JRL
Syva Co.
Chemistry · 27d
Cleared Feb 23, 1982
STER-O-DOSE
K820227 · CAF
Inhalation Therapy Equipment, Co.
Anesthesiology · 27d
Cleared Feb 23, 1982
DIGOXIN RADIOIMMUNOASSAY
K820274 · DPB
American Diagnostic Corp.
Toxicology · 21d
Cleared Feb 23, 1982
MICRO-AIRE REPLACEMENT DRILL BURS
K820281 · GFF
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 21d
Cleared Feb 23, 1982
SIGMA 2000 GAS CHROMATOGRAPH
K820283 · KZQ
The Perkin-Elmer Corp.
Toxicology · 21d
Cleared Feb 23, 1982
SYVA ADVANCE SY. EMIT-AMD GENT. CONTROL
K820286 · LAS
Syva Co.
Toxicology · 21d
Cleared Feb 23, 1982
EMIT AND NETILMICIN CONTROL
K820323 · LAS
Syva Co.
Toxicology · 18d
Cleared Feb 23, 1982
EMIT AND NETILMICIN ASSAY
K820324 · LCE
Syva Co.
Toxicology · 18d
Cleared Feb 23, 1982
IMPACT, MODEL E-12
K820330 · JCX
Impact Instrumentation, Inc.
General & Plastic Surgery · 15d
Cleared Feb 23, 1982
IMPACT, MODEL 302
K820331 · JCX
Impact Instrumentation, Inc.
General & Plastic Surgery · 15d
Cleared Feb 23, 1982
NEEDLE & BLADE COUNTER
K820332 · FSM
Abco Dist.
General & Plastic Surgery · 15d
Cleared Feb 23, 1982
ISLAM BONE MARROW BIOPSY NEEDLE
K820339 · GDM
Downs Surgical , Ltd.
General & Plastic Surgery · 15d
Cleared Feb 22, 1982
HEMOTOLOGY CALIBRATOR
K813530 · KSA
American Dade
Hematology · 67d
Cleared Feb 22, 1982
MODEL 3000C CALORIC IRRIGATOR
K813552 · ETP
Life-Tech Intl., Inc.
Ear, Nose, Throat · 63d
Cleared Feb 22, 1982
CARDIO-BAND
K813566 · LDQ
Cardio-Band, Inc.
General & Plastic Surgery · 62d
Cleared Feb 22, 1982
INTELECT MODEL 200
K813593 · IMI
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Feb 22, 1982
INTELECT MODEL 700
K813594 · IMG
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Feb 22, 1982
RAPID ZYME
K813612 · JTO
Dms Laboratories
Microbiology · 55d
Cleared Feb 22, 1982
RAPID CH
K813613 · JTO
Dms Laboratories
Microbiology · 55d
Cleared Feb 22, 1982
VERSATOME I
K820008 · HQE
Alphamedix, Inc.
Ophthalmic · 49d
Cleared Feb 22, 1982
URETHAL CUTTER CLAMP
K820015 · KOA
Lone Star Medical Products, Inc.
Gastroenterology & Urology · 48d
Cleared Feb 22, 1982
CERILLIUM
K820049 · EJH
Jelrus Technical Products Corp.
Dental · 45d
Cleared Feb 22, 1982
REVERSIBLE HYDROCOLLOID IMPRESSION MAT
K820061 · ELW
Belport Co., Inc.
Dental · 42d