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
85393–85416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1999
DCI ENDOSCOPE
K991171 · GCJ
Karl Storz Endoscopy
General & Plastic Surgery · 77d
Cleared Jun 23, 1999
HYDROTONE-THERMAL CAPSULE SYSTEM
K991184 · ILJ
Nats Corp.
Physical Medicine · 76d
Cleared Jun 23, 1999
DEFLECTABLE ELECTROSURGICAL PROBES
K991190 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 76d
Cleared Jun 23, 1999
ENDOSCOPIC FIBEROPTIC CABLE
K991208 · HBI
Isolux America
General & Plastic Surgery · 75d
Cleared Jun 23, 1999
DCI ENDOSCOPE
K991228 · GCJ
Karl Storz Endoscopy
General & Plastic Surgery · 72d
Cleared Jun 23, 1999
HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K991304 · LZA
M.R.G. Industries Sdn. Bhd.
General Hospital · 68d
Cleared Jun 23, 1999
ACCUTRED SHOE
K991313 · IRN
Orthopedic Technology Research, Inc.
Physical Medicine · 68d
Cleared Jun 23, 1999
HAL SCOPE HOLDER SYSTEM
K991548 · KKX
Noved Medical
General Hospital · 51d
Cleared Jun 23, 1999
JELTEMP
K991564 · EBG
J.F. Jelenko & Co., Inc.
Dental · 49d
Cleared Jun 23, 1999
ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION...
K991743 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 33d
Cleared Jun 23, 1999
SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH...
K991744 · LZA
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 33d
Cleared Jun 23, 1999
ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A...
K991745 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 33d
Cleared Jun 23, 1999
ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH...
K991746 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 33d
Cleared Jun 23, 1999
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150...
K991748 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 30d
Cleared Jun 23, 1999
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50...
K991749 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 30d
Cleared Jun 23, 1999
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50...
K991750 · LYY
Brightsway Holdings Sdn Bhd
General Hospital · 30d
Cleared Jun 23, 1999
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150...
K991752 · LYY
Brightsway Holdings Sdn Bhd
General Hospital · 30d
Cleared Jun 23, 1999
MULTACHOICE INSTRUMENTS
K991814 · GEI
Dexide, Inc.
General & Plastic Surgery · 27d
Cleared Jun 23, 1999
DEXIDE BIPOLAR FORCEPS II ** DEVICE
K991859 · GEI
United States Surgical, A Division of...
General & Plastic Surgery · 22d
Cleared Jun 22, 1999
NAVIPORT DEFLECTABLE TIP GUIDING CATHETER
K974683 · DQY
Cardima, Inc.
Cardiovascular · 553d
Cleared Jun 22, 1999
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550,...
K982950 · IKT
Chalgren Enterprises, Inc.
Neurology · 305d
Cleared Jun 22, 1999
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL
K983344 · CGA
Dade Behring, Inc.
Chemistry · 272d
Cleared Jun 22, 1999
IMPACT BALLOON DILATION CATHETER
K983373 · KNQ
B. Braun/Mcgaw
Gastroenterology & Urology · 271d
Cleared Jun 22, 1999
ENDOPATH ENDOSCOPIC INSTRUMENTS
K984240 · GEI
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 207d