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
89569–89592 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1998
INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER
K981193 · MBI
Innovasive Devices, Inc.
Orthopedic · 75d
Cleared Jun 16, 1998
ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST
K981197 · DKZ
Tcpi, Inc.
Toxicology · 75d
Cleared Jun 16, 1998
WATER FILLED GUM SOOTHER
K981202 · KKO
Corium Corp.
Dental · 75d
Cleared Jun 16, 1998
ALLOYBOND
K981383 · KLE
Southern Dental Industries, Inc.
Dental · 61d
Cleared Jun 16, 1998
KERR HARD DENTURE RELINE MATERIAL
K981448 · EBI
Sybron Dental Specialties, Inc.
Dental · 55d
Cleared Jun 16, 1998
GC FUJI BOND LC
K981514 · KLE
GC America, Inc.
Dental · 49d
Cleared Jun 16, 1998
CA
K981578 · CJY
Abbott Laboratories
Chemistry · 43d
Cleared Jun 16, 1998
AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000
K981754 · CBN
Porter Instrument Co., Inc.
Anesthesiology · 29d
Cleared Jun 16, 1998
PHOS
K981759 · CEO
Abbott Laboratories
Chemistry · 28d
Cleared Jun 15, 1998
AIC - CHEK (HBAIC-I)
K973365 · LCP
Express-Med, Inc.
Hematology · 280d
Cleared Jun 15, 1998
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT
K974087 · LOS
Hewlett-Packard Co.
Cardiovascular · 229d
Cleared Jun 15, 1998
ETEST BENZYLPENICILLIN
K980335 · JWY
Ab Biodisk
Microbiology · 138d
Cleared Jun 15, 1998
SERAQUEST ANTI-SM
K980540 · LKP
Quest Intl., Inc.
Immunology · 123d
Cleared Jun 15, 1998
SERAQUEST ANTI-SSB
K980639 · LLL
Quest Intl., Inc.
Immunology · 116d
Cleared Jun 15, 1998
MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50
K980980 · FFX
Konigsberg Instruments, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 15, 1998
KSEA CALCUSPLIT
K981233 · FFK
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 73d
Cleared Jun 15, 1998
CCA-200
K981439 · EWO
Benson Medical Instruments Co.
Ear, Nose, Throat · 55d
Cleared Jun 15, 1998
COLOR-SLIDE RF
K981496 · DHR
Seradyn, Inc.
Immunology · 49d
Cleared Jun 15, 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT
K981632 · CIG
Roche Diagnostics/Boehringer Mannheim...
Chemistry · 38d
Cleared Jun 15, 1998
I-STAT COAGULATION CONTROL SET
K981752 · GGN
Biopool Intl., Inc.
Hematology · 28d
Cleared Jun 12, 1998
NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM
K973096 · KPI
Neotonus, Inc.
Gastroenterology & Urology · 297d
Cleared Jun 12, 1998
RESPIRTECHPRO
K973975 · BTL
Vortran Medical Technology 1, Inc.
Anesthesiology · 235d
Cleared Jun 12, 1998
COSGROVE CLAMP
K974769 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 172d
Cleared Jun 12, 1998
56 SERIES AEROSOL GENERATOR
K980074 · CAF
Project Marketing
Anesthesiology · 155d