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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
85441–85464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1999
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15...
K991362 · JBD
Morax
Hematology · 68d
Cleared Jun 21, 1999
DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE...
K991402 · GKZ
Dako Corp.
Hematology · 60d
Cleared Jun 21, 1999
MOUSE IGG1 NEGATIVE CONTROLS
K991454 · GKZ
Dako Corp.
Hematology · 56d
Cleared Jun 21, 1999
TENDER TOUCH SILICONE GEL PADS
K991478 · MDA
Capital Marketing Technologies, Inc.
General & Plastic Surgery · 54d
Cleared Jun 21, 1999
SELF CURE COMPOSITE
K991488 · EBF
Harry J. Bosworth Co.
Dental · 54d
Cleared Jun 21, 1999
FLC COMPOSITE
K991491 · EBF
Harry J. Bosworth Co.
Dental · 54d
Cleared Jun 21, 1999
HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
K991513 · FPA
I-Flow Corp.
General Hospital · 52d
Cleared Jun 21, 1999
NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER...
K991742 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 31d
Cleared Jun 18, 1999
DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM...
K982096 · GXY
Rapid Mfg. Co.
Neurology · 368d
Cleared Jun 18, 1999
HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT...
K990250 · LBT
Morax
Chemistry · 143d
Cleared Jun 18, 1999
DIRECT HDL-CHOLESTEROL REAGENT
K990581 · LBS
Kamiya Biomedical Co.
Chemistry · 115d
Cleared Jun 18, 1999
RS-4V MUSCLE STIMULATOR
K990697 · IPF
Rs Medical
Physical Medicine · 107d
Cleared Jun 18, 1999
RENAL LINK
K990953 · KPF
Baxter Healthcare Corp
Gastroenterology & Urology · 88d
Cleared Jun 18, 1999
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
K990969 · IXW
Konica Medical Corp.
Radiology · 87d
Cleared Jun 18, 1999
GENYX MEDICAL INJECTION NEEDLE
K990996 · FBK
Genyx Medical, Inc.
Gastroenterology & Urology · 85d
Cleared Jun 18, 1999
DIMENSION BITE
K991008 · ELW
Espe Dental AG
Dental · 84d
Cleared Jun 18, 1999
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
K991047 · LTZ
Hardcover Products, Inc.
Obstetrics & Gynecology · 80d
Cleared Jun 18, 1999
NORMA 10
K991243 · LNH
Odin Technologies , Ltd.
Radiology · 67d
Cleared Jun 18, 1999
EXPLOR-X 70
K991310 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 63d
Cleared Jun 18, 1999
CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
K991318 · KPS
Hitachi Medical Corp. of America
Radiology · 60d
Cleared Jun 18, 1999
PANATOME
K991518 · EHD
Imaging Sciences Intl., Inc.
Radiology · 49d
Cleared Jun 18, 1999
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
K991671 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 32d
Cleared Jun 18, 1999
CHIRON DIAGNOSTICS ACS: 180 FT3
K991692 · CDP
Chiron Diagnostics Corp.
Chemistry · 31d
Cleared Jun 18, 1999
HISPEED NX/I CT SCANNER SYSTEM
K991716 · JAK
Ge Medical Systems, Inc.
Radiology · 29d