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
128185–128208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 17, 1990
LATEX PATIENT EXAMINATION GLOVES
K897038 · LYY
Multi Trading Corp. of America, Inc.
General Hospital · 30d
Cleared Jan 17, 1990
LATEX PATIENT EXAMINATION GLOVES
K897047 · LYY
P.T. Gotong Rojong Djaja
General Hospital · 30d
Cleared Jan 17, 1990
DISPOSINEEDLE SHARPS DISPOSAL UNIT
K897095 · MMK
Specialites Septodont
General Hospital · 27d
Cleared Jan 16, 1990
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A
K893579 · GNX
Whittaker Bioproducts, Inc.
Microbiology · 252d
Cleared Jan 16, 1990
BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH
K894510 · HCC
Capscan Corp.
Neurology · 181d
Cleared Jan 16, 1990
RIA (CONDOM)
K895091 · HIS
La Technology Sdn. Bhd.
Obstetrics & Gynecology · 161d
Cleared Jan 16, 1990
EVER-SHARP BIOPSY FORCEPS
K895303 · HFB
Southwest Medical Mfg., Inc.
Obstetrics & Gynecology · 140d
Cleared Jan 16, 1990
MODEL 210 IMPEDANCE SYSTEM
K895443 · ETY
Virtual Corp.
Ear, Nose, Throat · 130d
Cleared Jan 16, 1990
MINI PRIMO PLUS ASP BEHIND-THE-EAR HEARING AID
K896057 · ESD
Rexton, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 16, 1990
HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A
K896216 · CBS
Hewlett-Packard Co.
Anesthesiology · 78d