FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
85921–85944 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 22, 1999
BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT
K990993 · JLW
Biocheck, Inc.
Chemistry · 90d
Cleared Jun 22, 1999
AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER
K990997 · IYE
Aktina Medical Physics Corp.
Radiology · 89d
Cleared Jun 22, 1999
VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO,...
K991005 · LLB
Dayspring Medical, Inc.
Gastroenterology & Urology · 89d
Cleared Jun 22, 1999
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM
K991056 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 84d
Cleared Jun 22, 1999
TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
K991146 · JLW
Biocheck, Inc.
Chemistry · 78d
Cleared Jun 22, 1999
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
K991191 · GAM
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 75d
Cleared Jun 22, 1999
BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150
K991199 · GXY
Biomed Products
Neurology · 75d
Cleared Jun 22, 1999
PRONTO DRY
K991248 · LYR
Medical Instruments Corporation Mic AG
Microbiology · 71d
Cleared Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BARBITURATES
K991440 · DIS
Roche Diagnostics Corp.
Toxicology · 57d
Cleared Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
K991443 · JXM
Roche Diagnostics Corp.
Toxicology · 57d
Cleared Jun 22, 1999
BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
K991637 · FTL
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 41d
Cleared Jun 22, 1999
MODIFICATION TO DIGIPAN
K991912 · EHD
Trophy Radiologie
Radiology · 15d
Cleared Jun 21, 1999
IMTEC BIOPIN
K982951 · DZL
Imtec Corp.
Dental · 301d
Cleared Jun 21, 1999
POWDER FREE VINYL EXAMINATION GLOVES
K983856 · LYZ
Shijiazhuang Brethern Plastic Co., Ltd.
General Hospital · 231d
Cleared Jun 21, 1999
POWDERED VINYL EXAMINATION GLOVE
K983893 · LYZ
Shijiazhuang Brethern Plastic Co., Ltd.
General Hospital · 231d