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
159553–159576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1982
Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY.
K821973 · DIF
Travenol Laboratories, S.A.
Toxicology · 18d
Cleared Jul 20, 1982
ANGIOGRAPHY KIT
K821976 · DQO
Mallinckrodt Critical Care
Cardiovascular · 14d
Cleared Jul 20, 1982
LAVAGING CATHETERS
K822061 · OCX
American Endoscopy, Inc.
Gastroenterology & Urology · 7d
Cleared Jul 20, 1982
ULTRASOUND AUTO SECTOR CARDIAC MODULE
K827610
Technicare Corp.
Radiology · 35d
Cleared Jul 20, 1982
TECHNICARE ULTRASOUND AUTO SECTOR B-SCAN ARM OPTION
K827652
Technicare Corp.
Radiology · 22d
Cleared Jul 19, 1982
PERCUTANEOUS TRACHEOSTOMY DEVICE
K821821
Frederic J. Toye, M.D.
Gastroenterology & Urology · 27d
Cleared Jul 16, 1982
PREG-PHILE B
K821676 · JHJ
Bio Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jul 16, 1982
AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR
K821895 · EBF
American Midwest
Dental · 18d
Cleared Jul 16, 1982
ORTHO CLASSICAL PATHWAY COMPL. TEST
K821898 · DBA
Ortho Diagnostic Systems, Inc.
Immunology · 18d
Cleared Jul 16, 1982
SYVA ADVANCE STANDARDIZATION KIT #2
K821937 · JIS
Syva Co.
Chemistry · 17d
Cleared Jul 16, 1982
SYVA ADVANCE STANDARDIZATION KIT #3
K821938 · JIS
Syva Co.
Chemistry · 17d
Cleared Jul 16, 1982
CARBAMAZEPINE FLOURESCENT IMMUNOASSAY
K821945 · KLT
American Diagnostic Corp.
Toxicology · 17d
Cleared Jul 16, 1982
MODULUS VERNI-TROL ANESTHETIC VAPORIZER
K821966 · CAD
Ohio Medical Products
Anesthesiology · 14d
Cleared Jul 16, 1982
ACETAMINOPHEN STAT-PAK REAGENT SET
K821969 · LDP
Clin Tech Diagnostics Corp.
Toxicology · 15d
Cleared Jul 14, 1982
ORTHO SPECTRUM III & ORTHO-MUNE OK
K820643 · LIZ
Ortho Diagnostic Systems, Inc.
Hematology · 128d
Cleared Jul 14, 1982
CORNEA PERSERVATION UNIT
K821170 · LYX
Xytex Corp.
Ophthalmic · 79d
Cleared Jul 14, 1982
SGPT REAGENT SET
K821207 · CKD
Omega Medical Electronics
Chemistry · 78d
Cleared Jul 14, 1982
SGOT REAGENT SET
K821209 · CIQ
Omega Medical Electronics
Chemistry · 78d
Cleared Jul 14, 1982
ARGYLE INTRAMEDICUT CATHETER KIT
K821324 · DYB
Sherwood Medical Co.
Cardiovascular · 71d
Cleared Jul 14, 1982
DESERET CAPACITY PLUS ELECTROSURG. PAD
K821356 · GEI
Warner-Lambert Co.
General & Plastic Surgery · 69d
Cleared Jul 14, 1982
DISPOSABLE SURGICAL SCRUB BRUSHES
K821497 · GEC
Medical Systems Research
General & Plastic Surgery · 56d
Cleared Jul 14, 1982
MODEL 16800 TREND RECORDER
K821612 · DSF
Healthdyne, Inc.
Cardiovascular · 42d
Cleared Jul 14, 1982
AS20 MONITORING SYSTEM
K821614 · DXN
Narco Scientific
Cardiovascular · 42d
Cleared Jul 14, 1982
THE SOFT PEDAL
K821696 · JOW
Habco Products, Inc.
Cardiovascular · 36d