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
130537–130560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892016 · LYY
Winhace Trading, Inc.
General Hospital · 120d
Cleared Jul 28, 1989
NON-STERILE LATEX EXAMINATION GLOVES
K892461 · LYY
Rahn Laboratories
General Hospital · 112d
Cleared Jul 28, 1989
PATIENT EXAM GLOVES (MFG. UNITED LION RUBBER)
K892489 · LYY
Chori America, Inc.
General Hospital · 112d
Cleared Jul 28, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892606 · LYY
Tritech Mfg. Industries, Inc.
General Hospital · 109d
Cleared Jul 28, 1989
DVM-4200 BLOOD FLOWMETER
K892707 · DPW
Koven and Assoc., Inc.
Cardiovascular · 105d
Cleared Jul 28, 1989
MEDI, ULTRA, CURI EXAM GLOVES
K893057 · LYY
Sinjaca Inc. Dba Sic Medical &...
General Hospital · 106d
Cleared Jul 28, 1989
WHITESIDE ORTHOLOC M.A. TOTAL KNEE SYSTEM
K893252 · JWH
Dow Corning Wright
Orthopedic · 91d
Cleared Jul 28, 1989
FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150
K893440 · FFS
Welch Allyn, Inc.
Gastroenterology & Urology · 86d
Cleared Jul 28, 1989
ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR
K893485 · BXN
Biometer Intl. A/S
Anesthesiology · 85d
Cleared Jul 28, 1989
LIFECARE 75 CONTROLLER
K893487 · LDR
Abbott Laboratories
General Hospital · 85d
Cleared Jul 28, 1989
GRIPPER II ACETABULAR CUP
K893584 · LWJ
Joint Medical Products Corp.
Orthopedic · 80d
Cleared Jul 28, 1989
CONCOA PRESSURE REGULATORS
K893621 · CAN
Concoa Controls Corp. of America
Anesthesiology · 78d
Cleared Jul 28, 1989
SURGICARE (R) SPECIALTY EXAMINATION GLOVES
K893756 · LYY
Inter Continental Health Care
General Hospital · 74d
Cleared Jul 28, 1989
LATEX EXAMINATION GLOVES
K893825 · LYY
Frank W. Winne & Son, Inc.
General Hospital · 65d
Cleared Jul 28, 1989
LATEX EXAMINATION GLOVES
K894195 · LYY
Jiahn Chiaur Enterprise Co., Ltd.
General Hospital · 44d
Cleared Jul 28, 1989
QUIDEL FOOD ALLERGEN SCREEN
K894253 · DHB
Quidel Corp.
Immunology · 38d
Cleared Jul 28, 1989
ELECTRO-LITE POWER WHEELCHAIR
K894344 · ITI
Damaco
Physical Medicine · 14d
Cleared Jul 27, 1989
ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER
K884271 · IYO
Acuson Corp.
Radiology · 289d
Cleared Jul 27, 1989
TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR
K884972 · GZJ
Futuremed Div. of Future Impex Corp.
Neurology · 239d
Cleared Jul 27, 1989
IMEX RHYTHM TEK
K890114 · DSH
Racom, Inc.
Cardiovascular · 197d
Cleared Jul 27, 1989
SYRINGE INFUSION PUMP
K890120 · FRN
Medfusion, Inc.
General Hospital · 197d
Cleared Jul 27, 1989
PERMAGUM PUTTY SOFT & PERMAGUM GARRANT
K890449 · ELW
Wacker-Chemie GmbH
Dental · 181d
Cleared Jul 27, 1989
AD-TECH'S DEPTH ELECTRODE
K891920 · GZL
Ad-Tech Medical Instrument Corp
Neurology · 122d
Cleared Jul 27, 1989
TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES
K892930 · CKA
Technicon Instruments Corp.
Chemistry · 97d