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
131785–131808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1989
MODIFIED STOCKERT-SHILEY VENOUS CATHETER
K890980 · DWF
Shiley, Inc.
Cardiovascular · 63d
Cleared May 01, 1989
NON-STERILE GAUZE SPONGE
K891054 · KHR
Dispomed, Inc.
Dental · 63d
Cleared May 01, 1989
OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT
K891140 · EBC
Coe Laboratories, Inc.
Dental · 59d
Cleared May 01, 1989
GENERAL ELECTRIC AMX II
K891142 · IZL
Pro-Tronics, Inc.
Radiology · 59d
Cleared May 01, 1989
MICROTRAK EIA AUTOWASHER
K891269 · JYC
Syva Co.
Microbiology · 53d
Cleared May 01, 1989
INSERTION TOOLS
K891617 · DZE
Implant Innovations International, Inc.
Dental · 42d
Cleared May 01, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891735 · LYY
Harry Panzer Intl. Corp.
General Hospital · 40d
Cleared May 01, 1989
GENETIC SYSTEMS PIPETTOR/DILUTOR
K891765 · JTC
Genetic Systems Corp.
Microbiology · 38d
Cleared May 01, 1989
GENETIC SYSTEMS MICROPLATE STRIP WASHER
K891766 · JTC
Genetic Systems Corp.
Microbiology · 38d
Cleared May 01, 1989
GENETIC SYSTEMS MICROPLATE WASHER
K891768 · JTC
Genetic Systems Corp.
Microbiology · 38d
Cleared May 01, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892011 · LYY
Mediglove Sdn. Bhd.
General Hospital · 32d
Cleared May 01, 1989
PATIENT EXAM GLOVES (MFG. TAN CHONG RUBBER GLOVES)
K892030 · LYY
Behn Meyer & Co. (M) Sdn Bhd
General Hospital · 31d
Cleared May 01, 1989
DENTAL ROOT ELEVATOR
K892255 · EKO
Zinnanti Surgical Instruments, Inc.
Dental · 27d
Cleared May 01, 1989
SLT CONTACT LASER SYSTEMS (GYNECOLOGY)
K892346 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 26d
Cleared May 01, 1989
CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE
K892521 · FZS
Cymed, Inc.
General & Plastic Surgery · 20d
Cleared Apr 28, 1989
SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI
K883670 · GNP
Electro-Nucleonics, Inc.
Microbiology · 253d
Cleared Apr 28, 1989
LATEX NON-STERILE EXAM GLOVES
K890496 · LYY
Cal-American Exports, Inc.
General Hospital · 92d
Cleared Apr 28, 1989
SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS)
K890513 · OLZ
Micro Tronics Corp.
Neurology · 86d
Cleared Apr 28, 1989
GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K890789 · LNH
Philips Medical Systems North...
Radiology · 72d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVES
K890965 · LYY
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 60d
Cleared Apr 28, 1989
PHYNE-TOUCH (PATIENT EXAMINATION GLOVES)
K890983 · LYY
Medical Resources, Ltd.
General Hospital · 60d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891147 · LYY
Glove Seal Sdn Bhd
General Hospital · 56d
Cleared Apr 28, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891158 · LYY
Golden Earth Corp.
General Hospital · 53d
Cleared Apr 28, 1989
SUMMIT PATIENT EXAMINATION GLOVE
K891171 · LYY
Terng Nan Industrial Corp.
General Hospital · 53d