FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
125665–125688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1990
GC-01 THROUGH GC-99 ACETATE CONCENTRATE
K901473 · KPO
Granite Chemical Co., Inc.
Gastroenterology & Urology · 121d
Cleared Jul 27, 1990
DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION
K901477 · FKX
Delmed, Inc.
Gastroenterology & Urology · 122d
Cleared Jul 27, 1990
DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION
K901478 · FKX
Delmed, Inc.
Gastroenterology & Urology · 122d
Cleared Jul 27, 1990
QUIDEL CHLAMYDIA TEST
K901660 · LJC
Quidel Corp.
Microbiology · 108d
Cleared Jul 27, 1990
BIOCHEM 9100 MULTIGAS MONITOR
K901861 · CCK
Biochem International, Inc.
Anesthesiology · 93d
Cleared Jul 27, 1990
URESIL ENDOSCOPIC LASER OVERTUBE
K901882 · KOQ
Uresil Corp.
Dental · 92d
Cleared Jul 27, 1990
DITER ULTRASONIC S 3000
K901950 · IMI
Diter Elektroniikka OY
Physical Medicine · 87d
Cleared Jul 27, 1990
RAREX & OPTEX X-RAY SCREENS
K902039 · EAM
Mci Optonix, Inc.
Radiology · 84d
Cleared Jul 27, 1990
T19S BIOPSY NEEDLE
K902077 · KNW
Ohio Medical Instrument Co., Inc.
Gastroenterology & Urology · 80d
Cleared Jul 27, 1990
MODEL TR RECTAL SUCTION BIOPSY TUBE
K902097 · FCK
Medical Measurements, Inc.
Gastroenterology & Urology · 80d
Cleared Jul 27, 1990
PERITONEAL CATHETERS
K902101 · FJS
Akcess Medical Products, Inc.
Gastroenterology & Urology · 80d
Cleared Jul 27, 1990
PALAPRESS(R) VARIO RESIN
K902115 · EBI
Kulzer, Inc.
Dental · 78d
Cleared Jul 27, 1990
LAKE GASTROSTOMY TUBE
K902121 · KGC
Lake Medical Products, Inc.
Gastroenterology & Urology · 77d
Cleared Jul 27, 1990
ESCORT MODEL 400T TELEMETRY ECG MONITOR
K902254 · DXH
Medical Data Electronics
Cardiovascular · 67d
Cleared Jul 27, 1990
FLEXIBLE SNARE
K902265 · FDI
Annex Medical, Inc.
Gastroenterology & Urology · 67d
Cleared Jul 27, 1990
HEMA-SCREEN
K902360 · KHE
Immunostics Co., Inc.
Hematology · 59d
Cleared Jul 27, 1990
GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER
K902481 · FJI
Gambro, Inc.
Gastroenterology & Urology · 52d
Cleared Jul 27, 1990
AR-1600G AUTO-REFRACTOMETER
K902500 · HKO
Nidek, Inc.
Ophthalmic · 52d
Cleared Jul 27, 1990
EMIT(R) II OPIATE ASSAY
K902577 · DJG
Syva Co.
Toxicology · 46d
Cleared Jul 27, 1990
EMIT(R) II COCAINE METABOLITE ASSAY
K902579 · DIO
Syva Co.
Toxicology · 46d
Cleared Jul 27, 1990
EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)
K902581 · DKB
Syva Co.
Toxicology · 46d
Cleared Jul 27, 1990
CUT RESISTANT GLOVE LINER
K902633 · LYU
Biomet, Inc.
General Hospital · 43d
Cleared Jul 27, 1990
BPA, BODY POSITION ALARM
K902669 · LZW
Bagrad
Physical Medicine · 39d
Cleared Jul 27, 1990
SECUTAINER
K902709 · JKA
Preserve
Chemistry · 37d