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
127585–127608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 1990
GASTRIC SUMP TUBE
K896210 · KNT
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 84d
Cleared Jan 18, 1990
CYSTOSCOPY/IRRIGATION SET
K896211 · KOD
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 84d
Cleared Jan 18, 1990
Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET
K896213 · KOD
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 84d
Cleared Jan 18, 1990
VIRAFREE CORP. EJECTABLE NEEDLE HOLDER
K896293 · FMI
Virafree Corp.
General Hospital · 79d
Cleared Jan 18, 1990
GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK
K896346 · FPA
Pharmacia Deltec, Inc.
General Hospital · 76d
Cleared Jan 18, 1990
MIDA SYSTEM, MODELS 1000/1100
K896396 · DYC
Medical Graphics Corp.
Cardiovascular · 73d
Cleared Jan 18, 1990
MEDILOG OPTIMA
K896535 · DSK
Oxford Medilog, Inc.
Cardiovascular · 65d
Cleared Jan 18, 1990
ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC.
K896569 · DRX
Jason Marketing Co.
Cardiovascular · 59d
Cleared Jan 18, 1990
CLINISTAT ALBUMIN REAGENT TEST
K896910 · CIX
Miles Diagnostics Div.
Chemistry · 38d
Cleared Jan 18, 1990
T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT
K896925 · KHQ
In Vitro Diagnostics, Inc.
Chemistry · 37d
Cleared Jan 18, 1990
VISION THEOPHYLLINE II
K896927 · KLS
Abbott Laboratories
Toxicology · 37d
Cleared Jan 18, 1990
EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY
K897114 · KLT
Syva Co.
Toxicology · 23d
Cleared Jan 18, 1990
LD-1
K900107 · DET
Boehringer Mannheim Corp.
Immunology · 9d
Cleared Jan 17, 1990
STERILE LATEX SURGICAL GLOVE
K892899 · KGO
Tomarc (M) Sdn Bhd
General Hospital · 272d
Cleared Jan 17, 1990
VINYL EXAMINATION GLOVES
K892947 · LYY
Chung Kuo Industrial Co., Ltd.
General Hospital · 280d
Cleared Jan 17, 1990
LATEX EXAMINATION GLOVES
K893190 · LYY
Chia Huang Cotton Mfg. Co.
General Hospital · 274d
Cleared Jan 17, 1990
LATEX EXAMINATION GLOVES
K893273 · LYY
Tien Yee Screen Works Co., Ltd.
General Hospital · 275d
Cleared Jan 17, 1990
SURGITEK(R) EXTERNAL FILL PORT
K894495 · LCJ
Surgitek
General & Plastic Surgery · 182d
Cleared Jan 17, 1990
CORNER SEAT
K894767 · INN
Canadian Posture and Seating Centre,...
Physical Medicine · 175d
Cleared Jan 17, 1990
YUETONG LATEX EXAMINATION GLOVES
K895490 · LYY
The New York Whitney Group
General Hospital · 141d
Cleared Jan 17, 1990
PATIENT EXAMINATION GLOVE
K895576 · LYY
Yong XU Co, Ltd.
General Hospital · 125d
Cleared Jan 17, 1990
LATEX EXAMINATION GLOVES
K896016 · LYY
Sudinar Sdn Bhd
General Hospital · 92d
Cleared Jan 17, 1990
PFEIFFER METERED DOSAGE SYSTEM
K896070 · CCQ
Syva Co.
Anesthesiology · 90d
Cleared Jan 17, 1990
LATEX EXAMINATION GLOVES
K896094 · LYY
Matang Mfg. Sdn. Bhd.
General Hospital · 89d