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
101089–101112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1995
N 800 HF
K953831 · IZO
Nucletron-Oldelft Corp.
Radiology · 24d
Cleared Sep 08, 1995
BIOPSY NEEDLE
K953880 · KNW
Biopsys Medical, Inc.
Gastroenterology & Urology · 21d
Cleared Sep 08, 1995
URESIL INTRODUCING NEEDLE
K953923 · KNW
Uresil Corp.
Gastroenterology & Urology · 21d
Cleared Sep 08, 1995
FORCEPS
K953962 · GEN
Biopsys Medical, Inc.
General & Plastic Surgery · 17d
Cleared Sep 07, 1995
MTB 1043 TREATMENT BOOTH
K944133 · LGM
Mark Solutions, Inc.
General Hospital · 379d
Cleared Sep 07, 1995
HEARTCARD CARDIAC EVENT MONITOR
K944362 · DXH
Instromedix, Inc.
Cardiovascular · 365d
Cleared Sep 07, 1995
PREVENTOR AND PROTECTOR LATEX CONDOMS
K945246 · HIS
American Pharmaceutical Co., Inc.
Obstetrics & Gynecology · 315d
Cleared Sep 07, 1995
KARL STORZ SUCTION CATHETERS
K951250 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 171d
Cleared Sep 07, 1995
MARQUETTE DEFIB ELECTRODES
K952101 · MKJ
Marquette Electronics, Inc.
Cardiovascular · 126d
Cleared Sep 07, 1995
PPMI-(XXX) AND PPMO-(XXX)
K953231 · FPA
Patriot Products, Inc.
General Hospital · 150d
Cleared Sep 07, 1995
TYPE 1 & 2 (HUMIDAIR I & II)
K953507 · BYD
Icor AB
Anesthesiology · 43d
Cleared Sep 07, 1995
REVOLUTION BOND
K953592 · KLE
E&D Dental Products, Inc.
Dental · 37d
Cleared Sep 07, 1995
BOND-IT DUAL CURE ACTIVATOR
K953859 · KLE
Jeneric/Pentron, Inc.
Dental · 21d
Cleared Sep 06, 1995
TROPICAIR CONVECTIVE WARING SYSTEM
K946196 · DWJ
Seabrook Medical Systems, Inc.
Cardiovascular · 260d
Cleared Sep 06, 1995
KONICA LASER IMAGER LI-21
K950359 · LMC
Storch Amini & Munves PC
Radiology · 222d
Cleared Sep 06, 1995
PARKER MODEL PM
K950376 · IOL
Parker Treadmill Co., Inc.
Physical Medicine · 218d
Cleared Sep 06, 1995
PARKER MODEL PE
K950377 · IOL
Parker Treadmill Co., Inc.
Physical Medicine · 218d
Cleared Sep 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM
K950476 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 215d
Cleared Sep 06, 1995
PHACO TIP
K950881 · HQC
American Optical Corp.
Ophthalmic · 191d
Cleared Sep 06, 1995
OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES
K951671 · MEH
Osteonics Corp.
Orthopedic · 148d
Cleared Sep 06, 1995
GLUCOSE TEST ITEM NUMBER 97375/94
K951750 · LFR
Emd Chemicals, Inc.
Chemistry · 142d
Cleared Sep 06, 1995
3 LPM OXYGEN CONCENTRATOR
K952037 · CAW
Devilbiss Health Care, Inc.
Anesthesiology · 128d
Cleared Sep 06, 1995
TROPICAIR CONVECTIVE WARMING BLANKETS
K952086 · DWJ
Seabrook Medical Systems, Inc.
Cardiovascular · 126d
Cleared Sep 06, 1995
CHESHIRE
K952778 · LLZ
Perceptive Systems, Inc.
Radiology · 82d